Sean R. McKenna, Assistant U.S. Attorney Northern District of Texas

1. DOJ’s Enforcement of Nursing Home Failure of Care CasesNorth Texas Health Care Compliance Professional AssociationJune 19, 2007Dallas, Texas Sean R. McKenna, Assistant U.S. Attorney Northern District of Texas

2. Opinions expressed herein or otherwise are those of the speaker and do not necessarily reflect the views of the United States Attorney’s Office for the Northern District of Texas or the United States Department of Justice.

3. “We found a disturbing understatement of actual harm or higher deficiencies in a sample of surveys that were conducted since July 2000 at homes with a history of harming residents, but whose current surveys indicated no actual harm deficiencies.” July 17, 2003, Testimony of William J. Scanlon, GAO Director of Health Care Issues

4. Examples of Survey Findings • More than 25 maggots removed from a patient’s nostril and the tape holding in her nasogastrictube. • Staffing has been depleted badly. Patients are not receiving good care; there were 6 deaths this weekend. • Patient admitted about noon, died about midnight. Patient was supposed to be suctioned every 10-20 minutes. Patient not suctioned for the last 6.5 hours of her life and choked to death. • On Sunday 2 RNs and 2 CNAs covered 84 patients. One RN in one area for 18 critically ill patients.

5. Differing Enforcement Perspectives • Centers for Medicare and Medicaid Services and State Agencies • Remedies designed to ensure “substantial compliance” • Overwhelming majority of enforcement actions • Office of Inspector General (OIG) • Role in the most egregious failure of care cases • Cannot (nor should it) regulate long term care industry • U.S. Department of Justice (DOJ) • Array of criminal and civil remedies • Prevent recidivist facilities or persons from continuing to harm patients

6. DOJ’s Role in Enforcement • Seriously inadequate care provided by too many facilities • Residents often cannot find new facility, voice pain or suffering, or defend against violence or neglect • DOJ involvement is appropriate when: • Systemic failures to provide adequate care for which federal funds are paid; and • Failures have led to egregious patient outcomes such as serious injury or death

7. Conduct Giving Rise to Failures of Care • Systemic or widespread behavior, not isolated incidents • Knowing false statements to government • Actual harm or immediate jeopardy to residents • Facilities with histories of poor performance or “yo-yo” compliance involving the same or similar deficiencies • Management/executives creating, concealing, ignoring, or failing to correct problems

8. Civil False Claims Act • The False Claims Act (FCA), 31 U.S.C. § 3729 is the primary tool used in combating fraud against the United States • Exclusion authority under 42 U.S.C. § 1320a-7(b)(6)(B) • Persons who knowingly make or cause a false claim to the government. “Knowingly” means: • Actual Knowledge • Acting in deliberate ignorance or reckless disregard of the truth or falsity of the information • No specific intent to defraud • Remedies include penalties up to $11,000 per false claim, treble damages, and costs

9. FCA and Failure of Care Cases • Facilities should not be paid for a nonexistent, worthless, or grossly substandard item or service • Item or service was so grossly inadequate they are tantamount to the provision of nothing • Violate statutory, regulatory, or contractual certifications that are prerequisites for payments • Worthless services are archetype FCA failure of care case • During Civil War food was rotten, guns would not fire • Medicaid/Medicare paid for service (nursing care) that the facility knowingly did not provide as claimed

10. FCA and Failure of Care Cases (cont’d) • Facilities must ensure that nursing home residents achieve and maintain the “highest practicable physical, mental, and psychosocial well-being” • 42 U.S.C. § 1395i-3; 42 C.F.R. Part 483 • Potential FCA violation for “knowingly” seeking government funds for: • Having inadequate staff to provide required services • Failing to furnish adequate medical items or supplies • Failing to provide needed or required nursing care like repositioning, wound, restorative, or incontinence care

11. FCA Nursing Home Investigations • Review complaint or referral • What is the goal of the enforcement action? • Is DOJ involvement appropriate? • Assemble investigative team • Federal and/or State? • Review relevant documents • Statement of deficiencies • Survey history • Quality indicator reports • OSCAR reports • Compliant logs • Hospital incident reports

12. FCA Investigations (continued) • Investigation should be focused • Wounds and pressure sores • Restorative care • Therapeutic care • Staffing • Implementation of care plans • Basic grooming, bathing, and oral care • Interview State surveyors • Interview employees • Examples of specific deficient care • Additional residents harmed • Corporate and facility policies and practices • Corporate and facility personnel

13. FCA Investigations (continued) • Interview families of harmed residents • Issue subpoenas • Medical records • “Care” logs (skin logs) • Corporate and facility policy and procedures • Facility and corporate staffing charts and policies • Staff retention, recruiting, and marketing efforts • Relevant memoranda • 24 hour and incident reports • Documentation of decubitis ulcers and infections • Vendor payment invoices and records • Retain geriatric or nursing experts • Use of markers and medical reviews

14. Criminal Failure of Care Cases • American Healthcare Management, Inc., et al.; 4:05-cr-667-SNL (E.D. Mo. 2006) • Failed to provide adequate care at three nursing homes • Pled guilty to conspiracy to defraud Medicare and Medicaid • United States v. Borne, Jr., et al.; Criminal No. 03-247(E.D. La. 2006) • Diverted cash from nursing home for personal six-figure salary and make improvements to personal estate • Pled guilty to health care and pension fraud, sentenced to 37-months imprisonment, and ordered to forfeit nearly $4 million in property

15. Civil FCA Failure of Care Cases • United States v. NHC Health Care Corp., 163 F. Supp.2d 1051 (W.D. Mo. 2000) • Worthless services provided by nursing facility • “At some point the care rendered to a patient can be so lacking that the provider has simply failed to adhere to the standards it agreed to abide by and has thus committed a fraud.” • U.S. ex rel. Aranda v. Community Psychiatric Ctrs., 945 F. Supp. 1485 (W.D. Okla. 1996) • Worthless services furnished by psychiatric hospital • Violations of standard of care (i.e., Medicaid participation requirements) was FCA cause of action

16. Conclusion • Nursing home cases present complex issues • Intervention by DOJ is appropriate where: • Repeated failures of care • Demographic reasons • Economic reasons • DOJ is now involved in civil and criminal cases • Involvement only where necessary • Balanced approach • Coordination with other agencies

17. Questions