Massachusetts License Reinstatement Letter

							Office of Inspector General




          OIG Corporate Integrity
       Agreements, Exclusion Lists &
       Communication Requirements
                                       1
Overview
   OIG Exclusion Authorities
   Exclusion Referrals to OIG
   Quality of Care Enforcement Cases
   CIAs




                                        2
What is Exclusion?
 Effect of Exclusion
 Remedial
 Protect Federal health care programs
  and beneficiaries
 Permissive v. Mandatory




                                         3
Exclusion Authorities
 Mandatory Exclusion – criminal
  “conviction”
 Permissive Exclusion- 15 authorities
 http://oig.hhs.gov/fraud/exclusions/
  authorities.asp




                                         4
Referral Sources
   USAOs
   MFCUs
   Local prosecutors
   State Medicaid Agencies
   Licensing boards




                              5
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?



                                     6
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?

                                     7
When to report convictions
 Report convictions as soon as
  defendant is sentenced – even if
  appealed
 Referrals to the OIG Regional Office




                                         8
Documentation
 Judgment
 Plea agreement
 Indictment, information, etc.
 Investigative report or narrative, if
  necessary
 Aggravating factors
 Mitigating factors (including
  cooperation)
 Cover letter with a brief summary
                                          9
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   License has been revoked, suspended,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

                                            10
When and what to report
 Report as soon as the Board has
  taken final action
 Documentation requirements
     Final action and supporting

      information




                                    11
How do you know if someone is
excluded?
List of Excluded Individuals/Entities
(LEIE)

http://oig.hhs.gov/fraud/exclusions.asp




                                          12
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
                                          13
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
                                          14
Federal Prosecution Theories
(cont.)
 Administrative Sanctions
   “Worthless Services” theory
   Exclusion
   Civil monetary penalties




                                  15
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?


                                      16
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




                                        17
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
                                        18
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)
                                           19
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)
                                         20
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
                                           21
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?

                                     22
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
                                            23
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
                                                     24
Martha Bell and Atrium I
Nursing Home (con’t)
  Results:
    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

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



                                                    26
Cathedral Rock (2010) (cont.)
  Results:
      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




                                                    27
FORBA Holdings –
Small Smiles Centers (2010)
 Nationwide chain of pediatric dental
  clinics (68 clinics)
   Allegations:
     Substandard care
     Medically unnecessary services
     Pulpotomies (baby root canals),
      extractions, anesthesia, etc.



                                         28
FORBA Holdings –
Small Smiles Centers (2010) (cont.)
   Results:
     Settled for $24 million, plus interest
     5-year CIA
       “Quality of Care Dashboard”
       Chief Dental Officer
       Independent Monitor




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

                                                 30
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
                                               31
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


                                             32
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 chain-
  wide perspective
 Role of the Independent Monitor

                                       33
CIAs are publically available
 http://oig.hhs.gov/fraud/cias.asp




                                  34
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




                                                    35
Headquarters
Exclusions Staff
       Maureen R. Byer
       Director

       HHS/OIG/OI
       Exclusions Staff
       Suite 210
       7175 Security Boulevard
       Baltimore, MD 21244

       410-281-3060


                                 36
  OIG Regional Offices
Boston                        New York

Connecticut, Maine,           New Jersey, New York,
                              Puerto
Massachusetts, New Hampshire,
                              Rico, Virgin Islands
Rhode Island, Vermont

HHS/OIG/OI                    HHS/OIG/OI
Room 2475                     Room 13-124
JFK Federal Building          26 Federal Plaza
Boston, MA 02203              New York, NY 10278

617-565-2664                  212-264-1691

                                                      37
OIG Regional Offices
Philadelphia                      Atlanta

Delaware, District of Columbia,   Alabama, Georgia,
Maryland, Pennsylvania,           Kentucky, Mississippi,
Virginia, West Virginia           North Carolina, South
                                  Carolina, Tennessee

HHS/OIG/OI                        HHS/OIG/OI
Suite 326                         Suite 5T18
150 South Independence Mall       61 Forsyth Street, SW
    West                          Atlanta, GA 30303
Philadelphia, PA 19106

215-861-4586                      404-562-7603


                                                           38
OIG Regional Offices
Chicago                      Dallas

Illinois (except central     Arkansas, Louisiana, New
and southern), Indiana,      Mexico, Oklahoma, Texas
     Michigan,
Minnesota, Ohio, Wisconsin

HHS/OIG/OI                   HHS/OIG/OI
Suite 1330                   Room 629
233 North Michigan Avenue    1100 Commerce Street
Chicago, IL 60601            Dallas, TX 75242

312-353-2740                 214-767-8406

                                                        39
OIG Regional Offices
Kansas City                       San Francisco

Colorado, Illinois (central and   Alaska, Northern California,
southern), Iowa, Kansas,          Idaho, Oregon, Washington
Missouri, Montana, Nebraska,
North Dakota, South Dakota,
Utah, Wyoming

HHS/OIG/OI                        HHS/OIG/OI
Suite 920                         Suite 3-510
1201 Walnut                       90 7th Street
Kansas City, MO 64106             San Francisco, CA 94103

816-426-4000                      415-437-7961
                                                            40
OIG Regional Offices
Los Angeles                     Miami

Arizona, Southern California,   Florida
Guam, Hawaii, Nevada, Samoa,
Wake Islands

HHS/OIG/OI                      HHS/OIG/OI
Suite 1100                      Suite 306
600 West Santa Ana Boulevard    8100 Oak Lane
Santa Ana, CA 92701             Miami Lakes, FL 33016

714-246-8302                    305-530-7756



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