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Office of Inspector General

OIG Corporate Integrity Agreements, Exclusion Lists & Communication Requirements

OIG Exclusion Authorities Exclusion Referrals to OIG Quality of Care Enforcement Cases CIAs


What is Exclusion?
Effect of Exclusion Remedial Protect Federal health care programs and beneficiaries Permissive v. Mandatory


Exclusion Authorities
Mandatory Exclusion – criminal “conviction” Permissive Exclusion- 15 authorities authorities.asp


Referral Sources
USAOs MFCUs Local prosecutors State Medicaid Agencies Licensing boards


Should you refer a case to OIG for mandatory exclusion?
Was there a criminal conviction related to – Medicare or Medicaid fraud? Patient abuse or neglect? Felony health care fraud? Felony controlled substance?


Should you refer a case to OIG for permissive exclusion?
Was there a criminal conviction related to – Fraud related to a health care program operated by Federal, State, or local government agency? Obstruction of an investigation? Misdemeanor conviction relating to controlled substance?

When to report convictions
Report convictions as soon as defendant is sentenced – even if appealed Referrals to the OIG Regional Office


Judgment Plea agreement Indictment, information, etc. Investigative report or narrative, if necessary Aggravating factors Mitigating factors (including cooperation) Cover letter with a brief summary

License revocation or suspension?
1128(b)(4) Individual or entity License has been revoked, suspended, otherwise lost or voluntarily surrendered Professional competence, professional performance or financial integrity Length of exclusion – indefinite 1128(b)(4) - eligible for reinstatement once license is reinstated

When and what to report
Report as soon as the Board has taken final action Documentation requirements Final action and supporting information


How do you know if someone is excluded?
List of Excluded Individuals/Entities (LEIE)


Government Enforcement of Quality of Care
Enforcement priority DOJ, OIG, Medicaid Fraud Control Units Criminal, civil, and administrative cases Corporate Integrity Agreements (CIAs) Inter-governmental training, collaboration and monitoring

Federal Prosecution Theories
Criminal Violations Health care fraud False statements related to health care matters Mail fraud, conspiracy Civil False Claims False Claims Express or implied certification of compliance with statute or regulation

Federal Prosecution Theories (cont.)
Administrative Sanctions “Worthless Services” theory Exclusion Civil monetary penalties


Failure of Care/Worthless Services
Knowingly requesting payment for goods or services that were: Provided in a grossly deficient manner Key question: Did the government receive value for the bundle of services for which it paid?


When Does a “Failure of Care” Equal a Worthless Service?
Evidence of care so egregious it is worthless, or worse Systemic or widespread problems Evidence of harm to patients


What Does This Mean in Plain English?
Providers that: knowingly render grossly substandard or no care harm or kill patients (not a required element, but usually present), and bill Medicare or Medicaid for the alleged care May be pursued under the False Claims Act

OIG Exclusion Authorities Related to Quality of Care
Social Security Act § 1128 (42 U.S.C. 1320a–7) Mandatory exclusion Conviction related to patient abuse or neglect 1128(a)(2) Permissive exclusions License revocation 1128(b)(4)

OIG Exclusion Authorities Related to Quality of Care (cont.)
Items or services provided in excess of the patient’s needs 1128(b)(6)(B) Items or services which fail to meet professional standards 1128(b)(6)(B) False or fraudulent claims 1128(b)(7)

OIG’s Role in “Failure of Care” Cases
Investigate “failure of care” allegations Work on civil and criminal prosecutions Exclude appropriate individuals and entities Negotiate “Quality of Care” CIAs as part of the settlement of False Claims Act cases Monitor implementation of CIAs

Guideposts for Prosecution
Was there a systemic failure to address quality issues? Did the organization make false reports about quality? Did the organization profit from ignoring poor quality? Have patients/residents been harmed by poor quality?

Types of Cases DOJ and OIG do NOT Pursue
DOJ and OIG do not . . . Bring malpractice cases But malpractice cases are not a bar to government cases Bring administrative cases to enforce survey results But survey findings may be some evidence in an enforcement matter

Martha Bell and Atrium I Nursing Home (2005)
Pennsylvania nursing home and its administrator
Allegations: Falsification of medical records and billing records Substandard care – egregious; resident eloped and died Involuntary Manslaughter, Neglect Care of a Dependent Person, Recklessly Endangering Another Person, Criminal Conspiracy to Tamper with Physical Evidence

Martha Bell and Atrium I Nursing Home (con’t)
First Trial, Health Care Fraud (2005) Bell: 60 months in prison, $50,000 fine Atrium: 5 years of probation, $490,000 fine Second Trial, Cover-Up, Involuntary Manslaughter, etc. (2007) Bell: additional 22 to 44 months in prison

Cathedral Rock (2010)
Texas corporation, operated nursing homes in 4 states (25 facilities in 2004, 15 facilities in 2010)
Substandard care resulting in deaths and serious injuries Falsification of residents’ medical records


Cathedral Rock (2010) (cont.)
Settled FCA liability for $628,000 5-year CIA $1,000,000 in criminal fines and penalties Corporate officer and owner C. Kent Harrington entered into two-year DPA


FORBA Holdings – Small Smiles Centers (2010)
Nationwide chain of pediatric dental clinics (68 clinics)
Substandard care Medically unnecessary services Pulpotomies (baby root canals), extractions, anesthesia, etc.


FORBA Holdings – Small Smiles Centers (2010) (cont.)
Settled for $24 million, plus interest 5-year CIA
“Quality of Care Dashboard” Chief Dental Officer Independent Monitor


Emmanuel Bernabe (2009)
President and sole owner of a large California nursing home chain (29+ facilities)
Substandard care Failure to protect residents from accidents, neglect, abuse, etc. Chronic understaffing

Permanent Exclusion

Signs of Quality Problems
Financial, rather than clinical factors driving decisions about:
Admissions/census Bonuses and compensation Training, data collection and management

Too few staff, lack of staff competency Lack of focus on quality outcomes, process, culture, and data Failure to monitor and evaluate problems as they arise

Quality of Care CIAs
28 Quality of Care CIAs (as of 3/22/10) Different from other CIAs
Independent Monitor Quality Assurance Monitoring Committee Internal Audit Requirements Extensive policies and procedures Intensive training requirements Reporting


Purpose of Quality of Care CIA
Focus on systemic issues, not individual problems Focus on provider’s internal system of quality assurance and improvement Cross state boundaries with chainwide perspective Role of the Independent Monitor

CIAs are publically available


Contact Information
Lisa Re Deputy Chief Administrative & Civil Remedies Branch Office of Counsel to the Inspector General Department of Health & Human Services 202-205-9213


Headquarters Exclusions Staff
Maureen R. Byer Director HHS/OIG/OI Exclusions Staff Suite 210 7175 Security Boulevard Baltimore, MD 21244 410-281-3060


OIG Regional Offices
Boston New York
New Jersey, New York, Connecticut, Maine, Puerto Massachusetts, New Hampshire, Rico, Virgin Islands Rhode Island, Vermont HHS/OIG/OI Room 2475 JFK Federal Building Boston, MA 02203 617-565-2664 HHS/OIG/OI Room 13-124 26 Federal Plaza New York, NY 10278 212-264-1691

OIG Regional Offices
Delaware, District of Columbia, Maryland, Pennsylvania, Virginia, West Virginia

Alabama, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, Tennessee HHS/OIG/OI Suite 5T18 61 Forsyth Street, SW Atlanta, GA 30303

HHS/OIG/OI Suite 326 150 South Independence Mall West Philadelphia, PA 19106 215-861-4586



OIG Regional Offices
Illinois (except central and southern), Indiana, Michigan, Minnesota, Ohio, Wisconsin HHS/OIG/OI Suite 1330 233 North Michigan Avenue Chicago, IL 60601 312-353-2740

Arkansas, Louisiana, New Mexico, Oklahoma, Texas

HHS/OIG/OI Room 629 1100 Commerce Street Dallas, TX 75242 214-767-8406

OIG Regional Offices
Kansas City
Colorado, Illinois (central and southern), Iowa, Kansas, Missouri, Montana, Nebraska, North Dakota, South Dakota, Utah, Wyoming HHS/OIG/OI Suite 920 1201 Walnut Kansas City, MO 64106 816-426-4000

San Francisco
Alaska, Northern California, Idaho, Oregon, Washington

HHS/OIG/OI Suite 3-510 90 7th Street San Francisco, CA 94103 415-437-7961

OIG Regional Offices
Los Angeles
Arizona, Southern California, Guam, Hawaii, Nevada, Samoa, Wake Islands HHS/OIG/OI Suite 1100 600 West Santa Ana Boulevard Santa Ana, CA 92701 714-246-8302


HHS/OIG/OI Suite 306 8100 Oak Lane Miami Lakes, FL 33016 305-530-7756