Quality of care: Where we are and where we are going

Quality of care:Where we areand where we are going Health Care Compliance Association and American Health Lawyers Association October 6, 2009 Margaret L. Hutchinson Robert B. Ramsey, III, Esquire Assistant U.S. Attorney – Civil Division Buchanan Ingersoll, P.C. Office of the U.S. Attorney Eastern District of Pennsylvania

DISCLAIMER • Not U.S. Department of Justice Policy • In cases where there has not been a trial or guilty plea, government has duty to present evidence and carries burden of proof at trial, if defendants elect a trial • Allegations of indictment or complaint are not evidence

Theories of Liability for Quality of Care Cases Under the False Claims Act • Express False Certification • Implied False Certification • Worthless Service

Types of Quality of Care Cases: • Health Care Fraud • Nursing Homes • Hospitals • Home Health Care • Personal Care Homes • Children’s Facilities

General Quality of Care Issues • Staffing • Heavy reliance on agency staff? • Unqualified staff? • Not enough staff? • Wound Care/Bed Sores • Nutrition • Medication Errors • Diabetes Monitoring • Pain Management • Employee Response to Patient Complaints/Alarms • Geographically distant corporate management

Examples of Quality Of Care Cases In EDPA • Brighten at Broomall – Nursing Home • Central Montgomery Medical Center - Hospital • Lavin – Personal Care Home • Holland Glen – Children’s Facility • Southwood – Psychiatric Residential Treatment Facility

BRIGHTEN AT BROOMALL • Brighten at Broomall provided inadequate/worthless services regarding: • provision of adequate nutrition to meet the nutritional needs of residents, • provision of medication to residents, • monitoring weight loss • falls, • diabetic care, • pressure ulcer care, including the prevention and treatment of wounds, • incontinence care, and • care provided by physicians.

Brighten at Broomall – February 14, 2007 • In the settlement Brighten at Broomall has agreed to: 1. Payment of $45,000 to the government; 2. Creation of a Quality of Care/Quality of Life Fund in the amount of Twenty Thousand Dollars ($20,000) that will be used within a year to purchase services and/or equipment that would enhance the quality of life of the residents; 3. For the three year period of this Agreement, Brighten will use independent third-party consultants selected by the United States to assist in and assess Brighten at Broomall’s compliance with the settlement agreement; 4. Brighten at Broomall agrees to establish a Compliance Program that incorporates the policies and principles set forth in the OIG's Compliance Program Guidance for Nursing Facilities; 5. In addition to specific training contained in the settlement agreement, Brighten at Broomall shall conduct periodic training on an "as needed" basis at least semi-annually on those quality of care issues identified by the Quality Assurance Committee and the Internal Audit Program; and 6. Brighten will submit annual compliance reports to the OIG and the United States Attorney's Office.

Personal Care Home (“PCH”) Overview • Statistics • Approximately 1500 PCHs in Pennsylvania • Approximately 50,000 residents • Connection to Federal $$$$ • Residents/representative payees receiving Social Security (DIB)/SSI benefits • Approximately 60% of PA PCHs serve at least one resident receiving SSI • Approximately 20% of PCH residents are SSI recipients or have incomes equal to SSI recipients, who are low income, elderly, and persons with disabilities • Residents receiving veterans benefits

PCH Overview, cont. • Government Oversight • Licensed and inspected by the PA Department of Public Welfare • Services Provided • Room and board • Assistance with activities of daily living, e.g. eating, dressing and bathing • Assistance with medication administration • Assistance with finances • Transportation for medical care

U.S. v. LAVIN PCHs: JUNE 2008 SETTLEMENT • 4 Philadelphia-area PCHs owned by Rosalind Lavin • One home (Ivy Ridge – 30 to 60 residents) still open at time of settlement; two homes (Conlyn – 22 to 45 residents) (Thoroughgood – 40 to 70 residents) closed in 2002; one home (Brookwood – 30 to 35 residents) closed in 2000 • Many of residents at 4 homes received disability benefits from SSA that included DIB and/or SSI • PCH entities served as rep. payees for many such persons • U.S. alleged that, as rep. payees of SSI/DIB funds, entities failed to provide what federal law requires: necessary care, maintenance, housing, management, and fiduciary assistance to and on behalf of beneficiary-residents.

U.S. v. LAVIN SETTLEMENT, cont. • Among other provisions, the Settlement Agreement provided for: • Payment of $700,000 to the U.S. by the owners/entities • Cessation of PCH operations at Ivy Ridge, the then only still-operating facility • The entities/owners’ agreement never again to act as rep. payees of federal benefits • The entities/owners’ permanent withdrawal from participation in federal health care programs • A ban on the entities/owners ever again owning, co-owning, operating, consulting for, managing, or otherwise serving as officers, directors or agents for any government-funded or private pay facility at which care is provided • No admission of liability or wrongdoing

Holland Glen • Facility for medically fragile children • Licensed as community home for mentally retarded • In January 2008, the Government filed civil injunction proceeding in which U.S. alleged (i) should be licensed as nursing facility, and (ii) fraud (billing Medicaid for worthless services) in connection with, e.g.: • Failure to respond to respiratory alarms • Failure to use pulse oximeters, as ordered • Failure to care properly for wounds • Failure to assess and treat pain properly

Holland Glen Remedy • New temporary management • Nurse monitors for three years • Licensing and inspection now under the federal nursing facility quality of care regulations • Transfer of ownership to new entity

Remedies in Quality of Care Cases • “[b]ehind every claim for reimbursement is a program beneficiary” From: “In the Hands of Strangers: Are Nursing Homes Safeguards Working?” Testimony of Lew Morris before the House Subcommittee on Oversight and Investigations (May 15, 2008)

Remedies in Quality of Care Cases • In these cases, the Government has not merely sought recovery for its financial losses where there is an ability to pay but – to ensure good and ongoing patient care and safety – have searched out and sought remedies for root causes of deficient care such as: • Nurse monitors • Quality of life funds for residents • Staff training • Compliance programs/probation

Southwood Psychiatric Residential Treatment Facility • Facility provides residential based treatment for children suffering from psychological and behavioral disorders • Licensed by state • April 22, 2009,resolution of allegations of substandard care included $150,000 and extensive compliance measures

Southwood Resolution • Revamped National Compliance Plan for Parent Corporation • Appointment of Medical Director, Recreation Director, Clinical Director • Background checks and credentialing for staff • Staff training

Southwood Resolution (cont’d) • Written Standards for Clinical Topics, including: • Use of physical restraints • Therapeutic Care at individual level • Staff/resident ratios exceeding state requirements • Medical peer review process for patient eligibility • I.R.O. to monitor compliance

Where Do We Go From Here? • Quality Outcome Reporting • Data mining • Home health care and hospice care

Where Do YOU Go From Here? • Compliance program implications • Policies, training, auditing • Key issues to address

Quality of care: Where we are and where we are going