1. PRESENTED BY; DAWN M. CARMAN, JD, RHIA, FACHE DENALI COMPLIANCE GROUP, LLC TEMPORARY EMAIL: DAWNCARMAN@GMAIL.COMDAWNCARMAN@GMAIL.COM (COMPANY, WEBSITE, AND EMAIL ADDRESS PENDING) Quality of Care: Top Concern for Health Lawyers?

2. Agenda Quality Compliance Payers Regulators Enforcers

3. Disclaimer The content of this presentation is for general education purposes only. It is not to be construed as legal advice. For specific questions and issue guidance, please contact an attorney.

4. Who Is In The Driver’s Seat? Providers Payers Regulators Enforcers Quality Cost Access Consumers

5. Health Care Trends  Quality and patient safety  Pay for Performance (P4P)  Consumer driven health care  Physician-hospital collaboration and competition  Hospitalists  Physician compensation arrangements  Staffing shortages  Heal yourself health care  Retail clinic health care  More regulations  More enforcement

6. Quality

7. Quality Overview Organized medical groups  American Medical Association (1847)  American College of Surgeons Hospital Standardization Program (1917)  Medical Group Management Association (1926) Joint Commission (1952)  Medical record audits (1966)  Quality assurance (1979)  Continuous quality improvement (1988) Institute for Healthcare Improvement (IHI) (1991)  Measurable goals  No needless deaths  No needless pain or suffering  No helplessness in those served or serving  No unwanted waiting  No waste

8. Quality Overview Leapfrog Group (1998)  Aims  Reduce preventable medical mistakes and improve the quality and affordability of health care  Encourage health providers to publicly report their quality and outcomes so that consumers and purchasing organizations can make informed health care choices  Reward physicians and hospitals for improving the quality, safety and affordability of health care  Help consumers reap the benefits of making smart health care decisions  Baldrige Award  Six Sigma  Toyota Lean

9. Quality Overview Institute of Medicine Report (1999) To Err Is Human: Building a Safer Health System  Increased national awareness of health care quality  Emphasized patient safety  Supported mandatory error reporting systems  Set performance standards  Estimated 98,000 people die annually due to medical errors  Source: http://www.iom.edu/?id=12735http://www.iom.edu/?id=12735

10. Quality Overview Institute of Medicine Report (2001) Crossing the Quality Chasm: A New Health System for the 21 st Century  Outlined how to reinvent the health care system to foster innovation and improve the delivery of health care  Outcome measures for health care  Safe  Effective  Patient-centered  Timely  Efficient  Equitable  Source: http://www.iom.edu/CMS/8089.aspxhttp://www.iom.edu/CMS/8089.aspx

11. Compliance

12. Compliance Overview State licensing (late 1800’s) FDA federal medication regulation (1906) Social Security Act standards for maternal and children’s health care services (1935) Hill-Burton Act (1946)  Federal grants and guaranteed loans for hospital construction Medicare Conditions of Participation (1965)  Medical staff credentialing  Utilization review  Physician fiscal responsibility Joint Commission “deemed” status (1965) Professional Standards Review Organization (PSRO) established to decrease hospital utilization (1972)

13. Compliance Overview Prospective Payment Systems (1983) Peer Review Organizations (PROs) (1983)  Inspect and detect approach  To reduce readmission and unnecessary hospitalization  To lower death and complication rates  To identify physician quality of care issues  Physicians concerned that PROs generated more paperwork than improvement Health Care Quality Improvement Act (1986)  National Practitioner Data Bank  Medical malpractice claims settlements and awards  Hospital medical staff adverse actions EMTALA (1986)  Medical screening examination  Necessary stabilizing treatment  Regardless of ability to pay

14. Compliance Overview CMS (formerly Health Care Finance Administration) Health Care Quality Improvement Initiative (1992)  Changed PROs approach to data collection, its quality of care evaluation criteria, and its role in implementing quality initiatives  Focus on practice patterns  Evaluate quality using national, disease specific guidelines  Work collaboratively with hospitals and physicians on quality improvement initiatives  Source: http://www.cms.hhs.gov/http://www.cms.hhs.gov/

15. Compliance Overview DHHS OIG Compliance Guidance For Hospitals (1998)  7 elements of effective compliance program  No “one size fits all”  Goals  Optimize payment  Minimize billing mistakes (erroneous v. fraudulent claims)  Decrease chances of audits  Avoid conflicts with Stark and Anti-Kickback statutes  http://www.oig.hhs.gov/authorities/docs/cpghosp.pdf http://www.oig.hhs.gov/authorities/docs/cpghosp.pdf

16. Compliance Overview OIG Compliance Guidance for Individual and Small Group Physician Practices (2000)  7 elements of effective compliance program  No “one size fits all”  Goals  Optimize payment  Minimize billing mistakes (erroneous v. fraudulent claims)  Decrease chances of audits  Avoid conflicts with Stark and Anti-Kickback statutes  http://www.oig.hhs.gov/authorities/docs/physician.pdf http://www.oig.hhs.gov/authorities/docs/physician.pdf

17. OIG Compliance Guidance for Nursing Facilities (2000) http://www.oig.hhs.gov/authorities/docs/cpgnf.pdf Draft supplemental guidance pending (2008)

18. Compliance Overview DHHS OIG Supplemental Compliance Guidance For Hospitals  Risk assessments  A more thorough discussion of compliance fraud and abuse risk areas  Internal controls into processes  http://www.oig.hhs.gov/fraud/docs/complianceguidance/012 705HospSupplementalGuidance.pdf http://www.oig.hhs.gov/fraud/docs/complianceguidance/012 705HospSupplementalGuidance.pdf

19. The False Claims Act False Claims Act (1863)  An individual who knowingly submit, or cause another person or entity to submit, false claims for payment of government funds are liable for three times the government’s damages plus civil penalties of $5,500 to $11,000 per false claim  qui tam whistleblower provision  Examples:  A contractor falsifies test results or other information regarding the quality or cost of products it sells to the Government;  A health care provider bills Medicare for services that were not performed or were unnecessary, or;  A grant recipient charges the Government for costs not related to the grant.  AK no state false claims act

20. The False Claims Act The False Claims Act is about more than money. It is also about discouraging fraud and changing the culture of corporate America. As Sen. Charles Grassley (R-IA) and Rep. Howard Berman (D-CA) have noted: "Studies estimate the fraud deterred thus far by the qui tam provisions runs into the hundreds of billions of dollars. Instead of encouraging or rewarding a culture of deceit, corporations now spend substantial sums on sophisticated and meaningful compliance programs. That change in the corporate culture -- and in the values-based decisions that ordinary Americans make daily in the workplace -- may be the law's most durable legacy." Source: http://www.taf.org/whyfca.htmhttp://www.taf.org/whyfca.htm

21. Stark A conflict of interest law (1989) Intent to keep providers from self-referring patients for designated health services to facilities in which they have a financial relationship Designed to keep hospitals and providers from defrauding Medicare Penalties may include civil fines $15,000 - $100,000 or Medicare exclusion Exceptions apply

22. Anti-Kickback Statute Prohibits any knowing or willful solicitation or acceptance of any type of remuneration to induce referrals for health services that are reimbursable by the federal government (1972) Criminal statute Felonies with criminal penalties of up to $25,000 in fines and five years in prison Civil penalties can involve up to $50,000 in fines and exclusion from federal program participation

23. Compliance Overview Quality Improvement Organizations (QIOs) (2001)  Expanded role of QIOs in quality improvement initiatives  No published assessments of whether hospitals and physicians believe QIO interventions are improving quality Sarbanes-Oxley Act of 2002  Impacts heath care organizations  Applies to publicly traded health organizations  Best practices useful for non-profit health organizations  Impetus for enterprise risk management  More reliable and relevant documentation is necessary for financial statements and clinical quality measures US Sentencing Guidelines (2004)  Effective compliance and ethics program may reduce criminal sanctions  Board of directors must be involved in compliance programs  Adequate resources for compliance programs  http://www.ussc.gov/press/rel0404.htm http://www.ussc.gov/press/rel0404.htm

24. Compliance Overview Deficit Reduction Act of 2005  Medicare and Medicaid Integrity Programs  Gainsharing projects  Hospital Quality Data Payment Update Program expansion  http://www.cms.hhs.gov/DeficitReductionAct/ http://www.cms.hhs.gov/DeficitReductionAct/ Tax Relief and Healthcare Improvement Act of 2006  Physician Quality Reporting Initiative  1.5% bonus for physician participants  Quality measure registry reporting  http://www.cms.hhs.gov/PQRI/Downloads/PQRITaxReliefHealthCareAct.p df http://www.cms.hhs.gov/PQRI/Downloads/PQRITaxReliefHealthCareAct.p df IPPS and OPPS Cuts Continue  IPPS $20B cut  AHA said an “unnecessary and demoralizing blow against hospitals’ ability to care for patients across America”  http://www.aha.org/aha/press-release/2007/070801-st-finalippsrule.html http://www.aha.org/aha/press-release/2007/070801-st-finalippsrule.html

25. What Do Payers Want?

26. What Is P4P? Payment model that rewards hospitals and physicians for achieving certain performance measures for quality and efficiency Value-based purchasing Concept prevalent in other industries Gets away from resource-based fee-for-service reimbursement leaves little incentive for quality improvement Providers concerned that  Clinical practice guidelines have not undergone clinical trials  Patient non-compliance is out of their control  P4P will lead to broken physician-patient relationships  http://www.mgma.com/ http://www.mgma.com/

27. P4P CA P4P Project (2001)  Emerged from CA health care plans and physician groups developing a set of quality performance measures and a public report card the 1990s  Financial incentives based on utilization management were changed to quality measures

28. P4P National Voluntary Hospital Reporting Initiative (NVHRI)  Set forth in Medicare Modernization Act of 2003  Public-private joint effort  21 quality measures

29. P4P Medicare Quality Monitoring System (MQMS) (2003)  Part of CMS efforts to monitor and improve the quality of care delivered to Medicare beneficiaries  Early warning system for declines in quality of care  Quality indicators provided to Medicare beneficiaries  Utilization and outcome quality measures (as opposed to process quality measures) for many areas  http://www.cms.hhs.gov/QualityInitiativesGenInfo/15_MQMS.asp http://www.cms.hhs.gov/QualityInitiativesGenInfo/15_MQMS.asp

30. P4P Medicare Quality Monitoring System (MQMS)  Based on administrative data  Trends from 1992 though 2001  Various clinical and topic areas  Characteristics of Medicare beneficiaries and their utilization of health care  Acute myocardial infarction  Heart failure  Stroke  Pneumonia  Cardiovascular surgeries  Cancer surgeries

31. P4P Medicare Quality Monitoring System (MQMS)  National and state-level outcomes (not hospital-level outcomes)  Adjusted to a standardized distribution of age and sex; not otherwise risk adjusted  http://www.cms.hhs.gov/QualityInitiativesGenInfo/15_M QMS.asp http://www.cms.hhs.gov/QualityInitiativesGenInfo/15_M QMS.asp

32. P4P Premier Hospital Quality Demonstration (2006)  260 hospitals  34 quality measures  Public reporting of data  2% or 1% bonus (49/260 received a bonus)  2% or 1% penalty  http://www.cms.hhs.gov/HospitalQualityInits/35_hospitalpre mier.asp http://www.cms.hhs.gov/HospitalQualityInits/35_hospitalpre mier.asp

33. P4P The Physician Focused Quality Initiative (2004)  Implemented to  Assess the quality of care for key illnesses and clinical conditions that affect Medicare patients  Support physicians in providing appropriate treatment of the conditions identified  Prevent health problems that are avoidable, and  Investigate the concept of payment for performance  http://www.cms.hhs.gov/PhysicianFocusedQualInits/ http://www.cms.hhs.gov/PhysicianFocusedQualInits/

34. P4P Doctor's Office Quality Project (DOQ)  Designed to develop and test a comprehensive, integrated approach to measuring the quality of care for chronic disease and preventive services in the doctor's offices DOQ goals are to  Provide information for informed decision making  support and stimulate the adoption of quality improvement strategies by practitioners in doctor's offices CMS is working closely with key stakeholders such as nationally recognized physicians associations, consumer advocacy groups, philanthropic foundations, purchasers, and quality accreditation or quality assessment organizations to develop and test DOQ http://providers.ipro.org/index/doqit

35. P4P Medical Group Management Association (MGMA)  “A pay-for-performance program that conforms to certain established principles can potentially make health care programs more effective and efficient.”  9 principles  Goal must be to improve quality and safety  Physician participation must be voluntary  Practicing physicians must be involved in program design  Must use evidence-based performance measures  Must use adjusted data  Must reward physician participation  Medicare P4P must not be budget neutral  Must reimburse physicians for administrative costs  Physicians must be able to review and correct performance data Source: http://www.mgma.orghttp://www.mgma.org

36. P4P Physician Group Practice Demonstrations (2005)  Mandated by the Medicare, Medicaid, and SCHIP by the Benefits Improvement and Protection Act of 2000 (BIPA)  First P4P initiative for physicians under the Medicare program  Rewards physician for meeting performance measures for quality outcomes and efficiency  Disincentives for medical errors  Focused on large group practices (200+ physicians)  http://www.cms.hhs.gov/apps/media/press/release.asp? Counter=1341 http://www.cms.hhs.gov/apps/media/press/release.asp? Counter=1341

37. P4P Medicare Health Care Quality Demonstration (2006)  Medicare Modernization Act mandated 5 year demonstration program  Projects designed to enhance quality by  Improving patient safety  Reducing variations in utilization by appropriate use of evidence- based care and best practice guidelines  Encouraging shared decision making  Using culturally and ethnically appropriate care  Eligible participants include physician groups and integrated health systems  http://www.cms.hhs.gov/demoprojectsevalrpts/md/list.asp http://www.cms.hhs.gov/demoprojectsevalrpts/md/list.asp

38. P4P Physician Quality Reporting Initiative (PQRI)  Voluntary pay for reporting program started in 2007  Based on the Tax Relief and Health Care Act of 2006 (TRHCA)  Physicians collected and reported Medicare practice data for 74 performance measures between July and December 31, 2007  Participating physicians reporting on at least three performance measures on 80% of the eligible patients through out the full calendar year will receive a bonus from CMS  Challenges for sole practitioners  http://www.cms.hhs.gov/pqri/ http://www.cms.hhs.gov/pqri/

39. P4P Physician Quality Reporting Initiative (PQRI)  PQRI continues for January 1 through December 31, 2008  2008 PQRI quality measure specifications  http://www.cms.hhs.gov/PQRI/downloads/2008PQRIQualityMe asureSpecs123107.pdf http://www.cms.hhs.gov/PQRI/downloads/2008PQRIQualityMe asureSpecs123107.pdf  CMS physician education article on PQRI  http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM56 40.pdf http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM56 40.pdf  PQRI is considered by some experts to be a precursor to mandatory pay for performance (P4P)

40. P4P Physician Quality Reporting Initiative (PQRI)  2008 PQRI Coding For Quality Handbook provides coding and reporting principles and describes successful reporting for each measure:  http://www5.mgma.com/ecom/default.aspx?tabid=64&dest=http%3a%2 f%2fwww.mgma.com%2fWorkArea%2fshowcontent.aspx!id%3d15736%7c Ref%3dhttpzx0zx1zx1www.mgma.comzx1policyzx1default.aspxzx2idzx415 570 http://www5.mgma.com/ecom/default.aspx?tabid=64&dest=http%3a%2 f%2fwww.mgma.com%2fWorkArea%2fshowcontent.aspx!id%3d15736%7c Ref%3dhttpzx0zx1zx1www.mgma.comzx1policyzx1default.aspxzx2idzx415 570  CMS and AMA jointly developed PQRI data collection worksheets  http://www.ama-assn.org/ama/pub/category/17432.html http://www.ama-assn.org/ama/pub/category/17432.html  119 quality measures  http://www.cms.hhs.gov/PQRI/Downloads/2008PQRIMeasuresList.pdf ?agree=yes&nex http://www.cms.hhs.gov/PQRI/Downloads/2008PQRIMeasuresList.pdf ?agree=yes&nex  http://www.cms.hhs.gov/PQRI/15_MeasuresCodes.asp#TopOfPage http://www.cms.hhs.gov/PQRI/15_MeasuresCodes.asp#TopOfPage

41. P4P Medicare Care Management Performance Demonstration (2007)  Modeled on the “Bridges to Excellence” program  A 3 year P4P demonstration with physicians to promote the adoption and use of health information technology to improve the quality of patient care for chronically ill Medicare patients  Physicians who meet or exceed CMS performance standards in clinical delivery systems and patient outcomes will receive bonus payments for managing eligible Medicare beneficiaries  Focused on smaller practices in 4 states  http://www.cms.hhs.gov/DemoProjectsEvalRpts/downloads/MMA6 49_DesignReport.pdf http://www.cms.hhs.gov/DemoProjectsEvalRpts/downloads/MMA6 49_DesignReport.pdf

42. CMS Quality Focus CMS Hospital Quality Initiative Update  Accountability  Transparency  Hospital Compare  www.hospitalcompare.hhs.gov  Patients get  Quality information  Patient satisfaction information  Pricing information

43. OIG Quality And Compliance DHSS OIG/AHLA Guidance (2007) Corporate Responsibility and Health Care Quality: A Resource For Health Care Boards of Directors  Designed for health care organization boards  Consumers are demanding greater transparency and information about the care they receive  Medicare and other payors are linking payment to quality of care  Physicians are striving to deliver the highest quality care  Regulators are making health care quality a priority  Offers questions related to health care quality requirements, measurement tools, and reporting requirements that may be useful to those looking at quality of care issues  http://oig.hhs.gov/fraud/docs/complianceguidance/CorporateResponsibilit yFinal%209-4-07.pdf http://oig.hhs.gov/fraud/docs/complianceguidance/CorporateResponsibilit yFinal%209-4-07.pdf

44. OIG Quality And Compliance Board of directors oversight of quality of care Duty of care Good faith Reasonable person Best interest of organization Reasonable inquiry standard Balance between second guessing and due diligence

45. OIG Quality And Compliance DHHS OIG/HCCA Long Term Care Quality Guidance Driving For Quality In Long Term Care: A Board of Directors Dashboard (2007) http://www.oig.hhs.gov/fraud/docs/complianceguid ance/Roundtable013007.pdf http://www.oig.hhs.gov/fraud/docs/complianceguid ance/Roundtable013007.pdf

46. OIG Quality And Compliance Board of directors oversight of quality of care Dashboard tools Legal perspectives Clinical perspectives Commitment to quality Processes to monitor and improve quality Focus on quality outcomes

47. Health Law Trend Health Care Quality Tops List of Health Law Issues for 2008, says BNA Survey of Leading Health Law Attorneys NEWS RELEASE Arlington, Va. (January 7, 2008) – Patient care quality ranks at the top of the list of health law issues for 2008, according to an informal survey of health law attorneys by BNA's Health Law Reporter ™. Quality of care supplants fraud and abuse, which held the top spot for the previous two years. Source: American Health Lawyers Association

48. Enforcement

49. Medicare/Medicaid Conditions of Participation  The medical staff is accountable to the board to monitor quality  Corporate Integrity Agreements  Program exclusion Joint Commission  Deemed status substitute for COP  Loss of accreditation Government approach to improve quality in health care  Public reporting  Enforcing quality through the False Claims Act  Incentivizing quality through payment reform State Medicaid enforcement increases  CMS increases Medicaid integrity programs  See NY Medicaid Inspector General efforts  http://www.omig.state.ny.us/data/ http://www.omig.state.ny.us/data/

50. Enforcement OIG, DOJ, and State Attorneys General  Working together to enforce quality  Focus on medical necessity and failure of care  Penalties  $ fines  Criminal sanctions  Prison  Federal and state program exclusion  Corporate Integrity Agreements

51. FCA Prosecution Categories Ordering medically unnecessary services Payments of kickbacks Special treatment for frequent admitters Fraudulent documentation Lack or failure of appropriate internal review processes Underlying regulatory violations Source: C. Wagonhurst et al., Compliance and the Quality of Care Revolution, Health Lawyers News, Oct. 2007.

52. FCA Prosecutions Automatically running a lab test whenever the results of some other test fall within a certain range, even though the second test was not specifically requested Defective testing - Certifying that something has passed a test, when in fact it has not "Lick and stick" prescription rebate fraud and "marketing the spread" prescription fraud, both of which involve lying to the government about the true wholesale price of prescription drugs Unbundling - Using multiple billing codes instead of one billing code for a drug panel test in order to increase remuneration Bundling -- Billing more for a panel of tests when a single test was asked for Double billing - Charging more than once for the same goods or service Upcoding - Inflating bills by using diagnosis billing codes that suggest a more expensive illness or treatment Billing for brand -- Billing for brand-named drugs when generic drugs are actually provided Source: The False Claims Act Legal Center http://www.taf.org/whyfca.htmhttp://www.taf.org/whyfca.htm

53. FCA Prosecutions Automatically running a lab test whenever the results of some other test fall within a certain range, even though the second test was not specifically requested Defective testing - Certifying that something has passed a test, when in fact it has not "Lick and stick" prescription rebate fraud and "marketing the spread" prescription fraud, both of which involve lying to the government about the true wholesale price of prescription drugs  Lick and stick: pharmaceutical companies sold drugs at a discount to HMOs but did not afford state Medicaid programs the same rebates  Source: http://www.namfcu.net/press/press-release-2003-04-16/http://www.namfcu.net/press/press-release-2003-04-16/  Marketing the spread: pharmaceutical companies discount physician-administered drugs then the physicians charge government or private insurer more, pocketing the difference  Source: http://usawhistleblower.com/reportpharmafraud.htmlhttp://usawhistleblower.com/reportpharmafraud.html Unbundling - Using multiple billing codes instead of one billing code for a drug panel test in order to increase remuneration Bundling -- Billing more for a panel of tests when a single test was asked for Double billing - Charging more than once for the same goods or service Upcoding - Inflating bills by using diagnosis billing codes that suggest a more expensive illness or treatment Billing for brand -- Billing for brand-named drugs when generic drugs are actually provided Source: The False Claims Act Legal Center http://www.taf.org/whyfca.htmhttp://www.taf.org/whyfca.htm

54. FCA Prosecutions Phantom employees and doctored time slips: Charging for employees that were not actually on the job, or billing for made-up hours in order to maximize reimbursements Upcoding employee work: Billing at doctor rates for work that was actually conducted by a nurse or resident intern. Yield burning -- skimming off the profits from the sale of municipal bonds Falsifying natural resource production records -- Pumping, mining or harvesting more natural resources from public lands that is actually reported to the government Being over-paid by the government for sale of a good or service, and then not reporting that overpayment Misrepresenting the value of imported goods or their country of origin for tariff purposes False certification that a contract falls within certain guidelines (i.e. the contractor is a minority or veteran) Source: The False Claims Act Legal Center http://www.taf.org/whyfca.htmhttp://www.taf.org/whyfca.htm

55. FCA Prosecutions Billing in order to increase revenue instead of billing to reflect actual work performed Failing to report known product defects in order to be able to continue to sell or bill the government for the product. Billing for research that was never conducted; falsifying research data that was paid for by the U.S. government. Winning a contract through kickbacks or bribes Prescribing a medicine or recommending a type of treatment or diagnosis regimen in order to win kickbacks from hospitals, labs or pharmaceutical companies Billing for unlicensed or unapproved drugs Forging physician signatures when such signatures are required for reimbursement from Medicare or Medicaid Source: The False Claims Act Legal Center http://www.taf.org/whyfca.htmhttp://www.taf.org/whyfca.htm

56. Quality Case Law See Redding Medical Center  Unnecessary heart procedures  FCA  Settlement $54M  Required divestment from corporate parent  Corporate Integrity Agreement put in place See Lady of Lourdes Medical Center  Unnecessary medical procedures  FCA  Settlement $3.8M  Corporate Integrity Agreement put in place Source: C. Wagonhurst et al., Compliance and the Quality of Care Revolution, Health Lawyers News, Oct. 2007.

57. DHHS OIG Going full speed ahead with enforcement efforts in quality of care Sharing enforcement tools with states DRA whistleblower rights awareness Data mining for reimbursement and quality of care Focus on system failures Corporate Integrity Agreements  Fiscal integrity  Quality of care Never events $

58. Data Mining Technology to sort patient data to identify poor quality of care providers  Looks for quality patterns  Looks for fraud, waste, and abuse  Hospital Quality Initiative  Program for Evaluating Payment Patterns Electronic Report (PEPPER)  Comprehensive Error Rate Testing (CERT)  Payment Error Rate Measurement (PERM)  Recovery Audit Contractors (RACs)

59. Enforcement Historical enforcement  False Claims Act  Stark  Anti-Kickback Statute  Corporate Integrity Agreements New enforcement  Deferred prosecution agreements  Resolve criminal investigations  Cooperate with government  Waive right to speedy trial and statute of limitations  Take systematic remedial measures  Independent monitor Examples  Medical device company paying consultants to use its products  A medical center double billing Medicaid

60. Q&A