Compliance Lessons from Recent OIG Enforcement Activities. The Players. The Players Continued

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1 Compliance Lessons from Recent OIG Enforcement Activities Sarah Duniway, Gray Plant Mooty Sara DeSanto, University of Minnesota Physicians July 14, 2015 The Players Office of Inspector General (OIG) Part of Department of Health & Human Services (HHS) Charged with identifying, auditing, and investigating fraud, waste, and abuse in Medicare and Medicaid and more than 100 other HHS programs Also primary source of education and guidance for providers Just added new litigation team Department of Justice (DOJ) Responsible for federal law enforcement Health care fraud is a priority Criminal and civil fraud cases 2 The Players Continued Qui Tam Relators Private party (called relator or whistleblower) brings a False Claims Act case on the government's behalf The government considered the real plaintiff If the government/relator succeeds, the relator receives a share of the award Others State AG State Medicaid Fraud Units Others 3 1

primary source of education and guidance for providers Just added new litigation team Department of Justice (DOJ) Responsible for federal law enforcement Health care fraud is a priority Criminal and

2 The OIG 4 Trends in OIG Enforcement Activities Source: U.S. Dep't of Health & Human Servs., Office of Inspector Gen., Semiannual Report to Congress (April September 2014) 5 Trend: Physician Compensation Arrangements OIG Fraud Alert published on June 9, 2015 Follow-up to settlements with 12 individual physicians who entered into questionable medical directorships and office staff arrangements Spin-off CMP cases from FCA qui tam against imaging center and radiologist physician owner. OIG alleged the compensation paid to these physicians constituted improper remuneration under the antikickback statute because: The payments took into account the volume or value of referrals The payments did not reflect fair market value for the services The physicians did not actually provide the services The payments relieved the physicians of the financial burden of paying the salaries of their office staff 6 2

who entered into questionable medical directorships and office staff arrangements Spin-off CMP cases from FCA qui tam against imaging center and radiologist physician owner.

3 Trend: Physician Compensation Arrangements OIG Special Fraud Alert published on June 25, 2014 Addresses compensation paid by labs to referring physicians Supplement to previous guidance where OIG has repeatedly emphasized anti-kickback risk of providing free or below-market goods or services or paying more than FMV to a physician who is a source of referrals Highlighted two specific trends raising concerns about paying physicians for services not actually needed or for which physicians are otherwise compensated: 1) Payment for specimen collection and processing 2) Payment for data collection (Registry Arrangements) Warns that arrangements that carve out Medicare business can still implicate Anti-Kickback Statute 7 Trend: Physician Compensation Arrangements Physician Payment Sunshine Act Manufacturers (device and pharmaceutical companies) must report compensation to physicians and teaching hospitals Transparency trend Open Payments database now open OIG Work Plan Mid-Year Update Added review of financial interests reported under the Open Payments Program 8 Trend: Excluded Individuals Approximately 43% of all civil monetary penalty cases since July 2014 involved employment of excluded individuals 9 3

raising concerns about paying physicians for services not actually needed or for which physicians are otherwise compensated: 1) Payment for specimen collection and processing 2) Payment for data

4 Trend: Inadequate Documentation In 2014, OIG reported $2 billion in improper payments for home health care visits that lacked adequate documentation $7 billion in improper payments for doctor s office visits with insufficient documentation or improper coding CMP Cases Inpatient rehab facility: no documentation of physician concurrence with prescreening admission results ($750K) Physician practices: documentation did not support high level E&M services or prolonged service code ($80K); no documentation to support medical necessity of repeat tests ($485K) Physical therapy services: inadequate progress notes and unsigned or altered physician certifications of plans of care ($121K) 10 Trend: EHR Related Fraud or Sloppy Paste 2012 Center for Public Integrity and New York Times investigative reports: Since EHR adoption, seeing more high level office visits without evidence of increased care letter from HHS Secretary Sebelius and Attorney General Holder to industry: Concerns about misuse of EHR technology -- cloning and upcoding. A patient s care information... cannot be cut and pasted.... Law enforcement will take appropriate steps to pursue health care providers who misuse electronic health records to bill for services never provided and 2014 Office of Inspector General (OIG) Reports on EHR-Related Fraud Issues: Copy-pasting/cloning and over-documentation are fraud risks. CMS should issue guidance on use of copy-paste feature and advise contractors on detecting EHR fraud, including review of EHR audit trails OIG Work Plans: Will conduct billing reviews of multiple E/M services associated with the same providers and patients to assess for copy-paste abuses due to increased frequency of medical records with identical documentation across services. 11 Trend: Improper Credentials Submitting claims for services performed by professionals with lapsed or inadequate credentials 12 4

practices: documentation did not support high level E&M services or prolonged service code ($80K); no documentation to support medical necessity of repeat tests ($485K) Physical therapy services:

5 Trend: Qui Tam Cases Qui tam cases are increasing In 2014, there were over 700 qui tam cases and over $3 billion in recoveries 69% of FCA settlements with health care providers initially began as qui tam actions, accounting for 92% of the amounts recovered from this group Relators are developing new and creative ways to allege FCA violations 13 Trend: Self Disclosure Providers are required to return overpayments within 60 days Prompts self-disclosure of conduct Approximately 54% of all civil monetary penalty cases since July 2014 involved self-disclosure 14 Other Lessons from a Compliance Officer The OIG Work Plan is a great place to start, but it should not be the be-all end-all of your compliance program Assess other OIG guidance Scenario: Special Advisory Bulletin on pharmaceutical manufacturer copayment coupons (Sept. 2014) Emulate OIG tactics (e.g., data mining) Compliance Program Oversight OIG Guidance Document released in April 2015: Practical Guidance for Health Care Governing Boards on Compliance Oversight Make a good faith effort to keep up and comply! 15 5

return overpayments within 60 days Prompts self-disclosure of conduct Approximately 54% of all civil monetary penalty cases since July 2014 involved self-disclosure 14 Other Lessons from a Compliance

6 OIG Resources Fraud alerts Advisory opinions Special advisory bulletins Other guidance Compliance guidance documents Work Plan Summarizes new and ongoing reviews and activities that OIG plans to pursue Published annually with mid-year update Organized by provider-type Other reports and publications i.e., health care fraud and abuse control program reports 16 Questions? 17 6

that OIG plans to pursue Published annually with mid-year update Organized by provider-type

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