Fraud & Abuse Laws. Recent Activity and Other Compliance Concerns Keeping You Up At Night

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1 Fraud & Abuse Laws Recent Activity and Other Compliance Concerns Keeping You Up At Night Steven H. Pratt, Esq. Hall, Render, Killian, Heath & Lyman, P.C HEALTH LAW IS OUR BUSINESS.

2 AGENDA Government Emphasis on Fraud Overview of AKS, Stark & FCA DOJ Yates Memo Recent Cases U.S. ex rel. Barker v. Columbus Regional U.S. ex rel. Reilly v. North Broward U.S. ex rel. Payne v. Adventist c c 1992 OIG Letter Lessons 2

3 FEDERAL HEALTH CARE SPENDING TO EXCEED $1 TRILLION IN 2015 Federal spending for major health care programs will jump about 13% ($106 billion) in 2015 $49 billion will be for Medicaid outlays due to the enrollment of the program s newly eligible expansion population under section 2001 of the ACA Total federal health spending is expected to be about $1.035 trillion for 2015, while the CBO projects that by 2025, $1.899 trillion will go toward Medicare, Medicaid, health insurance subsidies, and the Children s Health Insurance Program (CHIP) Medicare program will grow at its fastest rate since 2009, increasing spending by about 7% ($35 billion) Medicaid enrollment will rise by 5 to 10% By 2025, an estimated $1.2 trillion will go to Medicare and $571 billion will fund Medicaid 3

4 GOVERNMENT EMPHASIS ON FRAUD Prosecuting fraud is good business invest $ $ 1 million 8 million return In 2015, an HHS report stated that for every $1 invested in OIG, DOJ and FBI investigations related to health care fraud in the past three years, $7.70 was returned. 4

5 ANTI-KICKBACK STATUTE Anti-Kickback Statute 42 U.S.C. 1320a-7b It is a civil or criminal offense for a hospital to: knowingly 1 and willfully solicit, receive, 2 offer or pay remuneration, directly or 3 indirectly, 4 overtly or covertly, in cash or in kind for referring or arranging Medicare or Medicaid services 5

6 6 ANTI-KICKBACK STATUTE

7 STARK LAW When a physician (or physician s immediate family member) has a financial relationship with an entity (*unless an exception applies), the federal Stark Law provides that: Physician may not make referrals to the entity for designated health services ; and Entity may not present a claim or bill to the government, patient, or any other party for designated health services furnished pursuant to a prohibited referral *If Stark applies, an exception must be found 7

8 FALSE CLAIMS ACT THE LINCOLN LAW 31 USC 3729 submitting a false claim or causing a false claim to be submitted WITH actual knowledge, deliberate ignorance, or reckless disregard VIOLATION 8

9 FALSE CLAIMS ACT THE LINCOLN LAW U.S. or private citizen (qui tam relator) may file claim Relator can receive 15 25% if U.S. recovers, and 25 30% if U.S. declines to intervene 9

10 RECENT SETTLEMENT AGREEMENTS Tenet Healthcare Agrees to $42.75 Million Settlement to Resolve Allegations it Overbilled Medicare (April 2012) Intermountain Healthcare Settlement of $25.5 Million Resulting from Stark Violations Revealed During Voluntary Disclosures (April 2013) Mercy Agrees to Pay United States $5.5 Million to Settle Alleged FCA Violations (August 2015) Tuomey verdict for $237 Million, settled at $72 Million Millennium Labs to Pay $256 Million in False Clams Act Settlements (October 2015) Columbus Regional settled FCA - $25-35 Million Adventist settled FCA - $118 Million North Broward settled FCA - $69.5 Million Novartis to Pay $390 Million to Settle Alleged False Claims Act Violations (October 2015) 10

11 11 FALSE CLAIMS ACT THE LINCOLN LAW

12 THE YATES MEMORANDUM DEPARTMENT OF JUSTICE 12

13 THE YATES MEMORANDUM DEPARTMENT OF JUSTICE expresses commitment to hold individuals accountable for illegal corporate conduct Individual Accountability for Corporate Wrongdoing Issued September memorandum outlines six key steps to strengthen the pursuit of individuals responsible for corporate wrongdoing applies to both civil and criminal investigations and prosecutions 13

14 THE YATES MEMORANDUM DEPARTMENT OF JUSTICE The Six Steps 1. In order for a corporation to receive cooperation credit, it must provide the DOJ with all relevant facts relating to the individuals responsible for the misconduct. 2. Criminal and civil corporation investigations will focus on individuals from the inception of the investigation. 3. Criminal and civil attorneys handling corporate investigations should be in routine communications with one another. 4. Absent extraordinary circumstances or approved departmental policy, the DOJ will not release culpable individuals from civil or criminal liability when resolving a matter with a corporation. 5. Department attorneys should not resolve matters with a corporation without a clear plan to resolve related individual cases, and should memorialize any declinations as to individuals in such cases. 6. Civil attorneys should consistently focus on individuals as well as the company and evaluate whether to bring suit against an individual based on considerations beyond that individual s ability to pay. 14

15 THE YATES MEMORANDUM DEPARTMENT OF JUSTICE Key Considerations Timely and complete disclosure of individuals Civil and criminal attorneys will be in communication Resolution of the corporate case no longer equates to resolution of the case against an individual An individual s ability to pay is irrelevant in the Department s analysis of whether to pursue an individual was misconduct actionable? admissible evidence? 15

16 THE YATES MEMORANDUM DEPARTMENT OF JUSTICE Compliance Make clear that all individuals are responsible for their actions Regardless of their position or seniority within the corporation Conflicts may arise between the organization and its employees Employees may be less willing to cooperate with internal investigations if they view themselves at risk Corporate counsel must be clear that they represent the company, not individual executives 16

17 3 KEY CONCERNS The complexity of hospital financial relationships with physicians, along with the ambiguity of the Stark law, have increased the frequency of prosecution and harsh consequences as a result of Stark violations Recent cases have illustrated the following three recurring themes: 1. Compensation amount is it FMV? 2. Compensation formula does it include payment based on volume or value of DHS referrals? 3. Is there proof of ulterior motives? 17

18 18 3 KEY CONCERNS

19 United States ex. rel. BARKER v. COLUMBUS REGIONAL HEALTH CARE SYSTEM 19

20 U.S. EX REL. BARKER V. COLUMBUS REGIONAL Settlement Columbus settled with the United States for $25-35 Million Physician will pay $425,000 20

21 U.S. EX REL. BARKER V. COLUMBUS REGIONAL Facts (as alleged) Excessive salary and directorship payments to physicians FMV Opinions for Oncologist, Dr. Andrew Pippas th percentile of medical oncologists nationally Paid $1.6 million 2009 Comp above all established benchmarks 2013 Determined his wrvu production was a combination of himself and three other provides Compensation exceeds FMV 21

22 U.S. EX REL. BARKER V. COLUMBUS REGIONAL Facts (as alleged) Compensation paid to Dr. Pippas with 40% higher than income earned from personally performed services Upcoding provided Dr. Pippas with a 54% higher income than a normal distribution of coding 22

23 U.S. ex rel. Barker v. Columbus Regional Internal documents listed 19 total Stark violations Physicians paid without contracts Physicians paid despite expired contracts Physicians paid in excess of contract compensation Multiple medical directors paid for the same service Expired lease agreements Uncollected rent payments Providing managerial services at no cost Physicians using space free of charge Some Bad Facts 20-year leases with no-rent escalator clauses CRHS determined self-reporting was not necessary because the relationship potentially fit within a Stark exception. 23

24 U.S. ex rel. Barker v. Columbus Regional Repeated Failure to Correct I cannot believe we have allowed this to continue..this is inexcusable and must be corrected immediately..i just cannot see how this went unaddressed. Columbus CEO It is very difficult to believe that here in Columbus, GA we have the top producer in the United States. - Columbus Chief Compliance Officer When you don t use outside firms and follow their guidance on FMV you find yourself in a lawsuit like Tuomey. Columbus CEO You cannot pay a physician without a contract unless you are willing to go to jail. You should only pay physicians according to the contracted terms to pay them more than what is stipulated in the contract is to subject yourself to possible jail time, CMPs, and the loss of your job. Columbus CEO 24

25 UNITED STATES EX. REL. REILLY v. NORTH BROWARD HOSPITAL DISTRICT, ET AL. 25

26 UNITED STATES EX. REL. REILLY V. NORTH BROWARD Settlement North Broward settled with the United States for $69.5 Million 26

27 UNITED STATES EX. REL. REILLY V. NORTH BROWARD Relator? Dr. Michael Reilly Orthopedic surgeon who held privileges to practice with hospital Offered employment that presented potential violations of the Federal Stark laws Declined employment, but continued to witness illegal recruiting strategies 27

28 UNITED STATES EX. REL. REILLY V. NORTH BROWARD Facts (as alleged) Hired orthopedic surgeons from competing hospital Internal documents confirmed the surgeons were not hired based on need, but because they were previously employed by a competitor Capture more inpatient/outpatient orthopedic cases If profits from revenue were not considered, hospital would have had net losses of over $1.3 million, plus the commitment of $1.5 to $2.5 million in startup capital. Agreed to construct a new $12 million ortho facility New physicians provided 28,000 patient visits which resulted in 4,300 surgeries over the last fiscal year. 28

29 UNITED STATES EX. REL. REILLY V. NORTH BROWARD Facts (as alleged) Practice overheads nearly 172% of collections Economically unviable if the parties were not in a position to generate and receive referral profits Bonus money based on inflated rates of compensation per wrvu Guaranteed base salaries in excess of their gross revenues from previous years Compensation to collection ratio was double the 90 th percentile for other orthopedic surgeons in the southern United States 29

30 UNITED STATES EX. REL. REILLY V. NORTH BROWARD Ulterior Motive? When shown a detailed profit and loss statement evidencing a $1.8 million operating loss for orthopedic surgeons in a year, the CEO stated: We are making money off of these guys. These numbers don t really include what they re bringing in with labs, P.T., diagnostics, etc. In planned budgets, all 48 employed physicians were budgeted at a net loss from operations Only 1 of the 48 physicians had a realized net gain 30

31 UNITED STATES EX. REL. REILLY V. NORTH BROWARD Ulterior Motive? Financial strategists budgeted for net operating losses while secretly tracking referral revenues from employed physicians. Analyzed expenses, overhead, revenue, and value/volume of referrals Contribution margin reports were concealed and maintained separate from regular financial reports When contribution margins are included, net operating losses from over-compensation of employed physicians becomes a multi-million dollar profit 31

32 UNITED STATES EX REL. PAYNE, ET AL. v. ADVENTIST HEALTH SYSTEM 32

33 U.S. ex rel. Payne v. Adventist Settlement Adventist settled with the United States for $118 Million 33

34 U.S. ex rel. Payne v. Adventist Excessive Compensation? Over 50 physicians were flagged as receiving more compensation than could be considered commercially reasonable based on MGMA reviews of compensation 34

35 U.S. ex rel. Payne v. Adventist Facts (as alleged) Corporate policy directing hospital to acquire physician practices and employ physicians to control patient referrals in the area Lost large sums of money on physician practices Above market salaries Bonuses Perks and Benefits Operating Expenses Tracked employed physician s contribution margin Revenue received by the hospital when attending and/or referring physician These margins resulted in substantial net gains Required employed physicians to refer to hospital Exception Report required for outside referrals 35

36 U.S. ex rel. Payne v. Adventist Facts (as alleged) Employed physicians received bonuses based on formula that took into account tests/procedures ordered Bonuses paid based on all revenue paid to the hospital in association with a physician s work, including facility fees payable to the hospital Practitioner Kickbacks Payments to Nurse Practitioner to maintain DSH status $200 for any patient that delivers baby at hospital with another provider babies per month Lab Kickbacks Physicians received the Medicare allowable rate for private pay patients Some made over $43,000 from this practice Pharmacy Kickbacks $1 for every patient signed up for hospital pharmacy 36

37 U.S. ex rel. Payne v. Adventist Facts (as alleged) Contractually forgave physician debt Lease payments for physician s BMW and Mustang Paying for staff, equipment, drugs, supplies, and medical malpractice insurance for physician s private practices Improper coding and billing practices 37

38 U.S. ex rel. Payne v. Adventist Facts (as alleged) CFO worried about going to jail for making Part A payments to physicians. No intention of reporting the issue to CMS because the amount of money due to the government would be insane Quietly stop and pray to God no one notices Yet, the payments did not stop 38

39 U.S. ex rel. Payne v. Adventist Ulterior Motive? CFO indicated in system wide that it is EXPECTED that physician practices lose money and therefore the cost report contains a section to add back the physician loss to determine profitability went to mid-level management, including relators After it was realized that this was considered purchasing referrals, employees were told to lose the spreadsheet and not to talk about it with lower level employees 39

40 40 U.S. ex rel. Payne v. Adventist

41 TRENDS AND TAKEAWAYS An increasing number of Stark Law cases are being brought under the False Claims Act Triple damages plus penalties These settlements demonstrate that the relators and the DOJ are focused on employed or acquired physician practices, which are more likely to operate at a loss Questions of commercial reasonableness if referrals are not considered The median loss for employing a physician is $176,463 41

42 TRENDS AND TAKEAWAYS 1992 OIG guidance Study the past if you would define the future. - Confucius 42

43 TRENDS AND TAKEAWAYS The OIG issued informal guidance on the AKS implications of hospitals acquiring physician practices in 1992 Letter concerning the application of the Medicare and Medicaid anti-kickback statute to certain types of situations involving the acquisition of physicians practices. 43

44 OIG LETTER Specific items that raise a question as to whether payment is being made for the value of a referral stream would include, among other things: Payment for goodwill Payment for value of ongoing business unit Payment for covenants not to compete Payment for exclusive dealing arrangements Payment for patient lists Payment for patient records 44

45 OIG LETTER Before vs. After Inquiry 1: [C]ompare the financial welfare of the physicians involved before and after the acquisition. If the economic position of these physicians is expected to significantly improve as a result of the acquisition, it is likely that a purpose of the acquisition is to offer remuneration for the referrals which these physicians can make to the buyer. Inquiry 2: [C]ompare referral patterns before and after the acquisition, specifically, whether the sellers become increasingly loyal to the buyer. 45

46 46 OIG LETTER

47 LESSONS 1. Strong policy on physician compensation both the amount and methodology. 2. Educate leadership. 3. Carefully manage communication culture of compliance. 4. Periodically review compensation formula. no DHS $, or qualify as Group Practice 5. Consider returning ancillary revenue to physician practice. 6. Show community need. What to do? 47

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