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Life Services Network
   2011 Annual Meeting
             March 23 – 25
Health Care Regulatory Exposures:
     An Evolving Landscape
            Katherine M. Keefe
          Chair, Health Care Practice
            Dilworth Paxson LLP

      Christopher M. Breck, CIC, ARM
       Managing Director of Healthcare
           Alper Services, LLC

              Sharon M. Livas
        Sr. Vice President – Healthcare
             Alper Services, LLC
Health Care Regulatory Exposures:
     An Evolving Landscape

 Illinois Workers Compensation Reform


         Christopher M. Breck, CIC, ARM
           Managing Director of Healthcare
               Alper Services, LLC

                 Sharon M. Livas
            Sr. Vice President – Healthcare
                 Alper Services, LLC
Illinois
Talks of Workers’ Compensation
            Reform
Illinois
Talks of Workers’ Compensation
            Reform
  Stakeholders
        Dr’s
        Business
        Labor
        Lawyers
        Workers
        Politicians
Illinois
Talks of Workers’ Compensation
            Reform



Most Expensive    Change in Rank
States            2008 vs. 2010
   Montana       2-1
   Alaska        1- 2
   Illinois      10 -3
   Oklahoma       9-4
   California    13 - 5
   Connecticut   20 - 6
   New Jersey    16 - 7
Illinois
Talks of Workers’ Compensation
            Reform
Current Causation
   Accident need only be a causative factor

   May be based on a sequence of events without
    medical testimony

   Aggravation of pre-existing condition
Illinois
Talks of Workers’ Compensation
            Reform
Proposed Causation
   Change work related condition to be “caused” by
    work as PRIMARY factor

   Current indefensible standard allowing work to
    be “a” cause not “the” cause.
Illinois
Talks of Workers’ Compensation
            Reform
Current Choice of Medical Care
    Employee has choice of up to 2 treating
    physicians and referrals

Proposed Choices for Medical Care

   1st choice to Employer; 2nd choice to Employee
Illinois
Talks of Workers’ Compensation
            Reform
Current AMA Standards
   Not applied in IL
    
    38 states recognize guidelines
Proposed AMA Standards
   Require objective findings of disability based on
    AMA guidelines
Illinois
Talks of Workers’ Compensation
            Reform
Current Wage Differential
   Lifetime benefit requires physical rather than
    economic change

   Unlimited Number of awards

   Based on Maximum state average weekly
    wage
Illinois
Talks of Workers’ Compensation
            Reform
Proposed Wage Differential
   Cap until Age 67 or 5 years post injury

   Allow modification based on a material increase in
    earnings

   Cap benefit at max PPD rate
Illinois
    Talks of Workers’ Compensation
                Reform
Current Intoxication Defense
      There is none
Illinois
    Talks of Workers’ Compensation
                Reform
Proposed Intoxication Defense
   Create rebuttable presumption that there will be NO
    benefits if alcohol level is . 08 or above or any other
    illegal substance OR refuses testing
Illinois
    Talks of Workers’ Compensation
                Reform
Current Fee Schedule
   Medical Fee Schedule 2nd highest in the country
    (WCRI)
Illinois
    Talks of Workers’ Compensation
                Reform
Proposed Schedule
   Reduce 15-20%

   Provide reimbursement for out of state
    procedures, treatments and supplies

   Cap reimbursements for Implants at cost plus of
    25%
Illinois
 Talks of Workers’ Compensation
             Reform
REFORM
+ EARLY INTERVENTION
    + SAFETY TRAINING
        + HIRING PRACTICES
                      =
   LOWER COSTS AND
 HEALTHY EMPLOYEES
Illinois
Talks of Workers’ Compensation
            Reform

   How does IL rank in costs?

   If my blood alcohol is .06, will my Work Comp
    clam be paid?

   What year were the last reforms made to the
    system?
Illinois
Talks of Workers’ Compensation
            Reform
   Why have medical costs increased faster in
    workers compensation vs. health plans?


   What can you personally do to help reforms be
    adopted in Illinois?
Health Care Regulatory Exposures:
     An Evolving Landscape
     Enforcement   Overview
     Specific areas of regulatory risk
        Acquired   conditions
        RAC
        Privacy
        Excluded   Individuals
     Compliance    Programs
I. Enforcement Overview
Overview of the Health Care Industry:
           Enforcement Agencies
   HHS Centers for Medicare & Medicaid Services
    (CMS)
   Food and Drug Administration (FDA)
   Office of Inspector General (OIG)
   Department of Justice (DOJ)
   Federal Bureau of Investigation (FBI)
   HHS Office of Civil Right (OCR)
   State Attorneys General
   Private Litigants
Centers for Medicare &
    Medicaid Services (CMS)


   Within HHS, administers Medicare, Medicaid,
    State Children's Health Insurance Program
    (SCHIP), HIPAA (transactions) CLIA, other
    programs
   90 million beneficiaries
   $650 billion budget
   "Stewards accountable for resources and
    effectiveness"
Office of Inspector General
                    (OIG)
   OIG mandated by law to protect integrity of HHS
    programs, and health and welfare of program
    beneficiaries
   OIG responsible to report to Secretary of HHS and
    Congress problems and recommendations
   OIG duties carried out through a nationwide
    network of audits, investigations and inspections
OIG Initiatives
   Annual work plans
   Self-disclosure protocol
      Recently refined
      Good faith disclosures
      Imposes Corporate Integrity/Compliance
       Agreements
   Compliance Program Guidance
      Provider-specific (i.e., hospital, home health,
       lab, DME)
      Nursing facility guidance
OIG 2011 Work Plan
   Senior services focus includes:
      Nursing home payment and oversight
      Assessment of atypical antipsychotic drugs
      Nursing home resident hospitalizations
      Criminal background checks for nursing home
       employees
      Emergency preparedness
FALSE CLAIMS ACT

   31 U.S.C. §§ 3729-2733 imposes civil liability
    against a person or entity that:
      Knowingly (can be shown by reckless disregard
       for the truth)
      Presents a false claim for payment, or
      Uses a false record or statement to get a claim
       paid or approved, or causes a third party to do
       either of above
   Treble damage award
   Additional penalty for each claim between $5,000
    and $11,000.
FCA Whistleblower ("Qui Tam")
               Provisions
   Private citizen whistleblower ("relator") files action
    and submits to U.S. Attorney for review
   Government investigates and decides whether to
    intervene
   If government does not intervene, relator may pursue
    action on his/her own, in the shoes of the
    government.
   Relator may receive
      up to 25% of award if government intervenes
      30% if government does not intervene and relator
       pursues
Majority of False Claim Actions Come
            from Whistleblowers
   Whistleblowers are
    everywhere

   From lower level
    employees to
    professionals or executive
    employees
Computation of FCA Judgment
   $334 million judgment (3/07) against AmeriGroup health plan
        Illinois hired Amerigroup to administer Medicaid managed
         care program
        Amerigroup alleged to have avoided pregnant women and
         others with expensive health conditions
        False Claims Action
        Whistleblower was former head of government relations;
         received between 15% and 25% of award.
        Judgment Total: Jury award: $48 million in damages,
         trebled (x3) = $144 million, judge assessed penalty of
         $10,500 on each of 18,130 claims = $190,365,000
         TOTAL: $334 million.
        Other costs – employee time and lawyers' fees
Social Security Act
               Relevant Provisions

   42 U.S.C. § 1320a-7: Exclusion of individuals and
    entities from participation in Medicare and State
    health care programs
   42 U.S.C. § 1320a-7a: Civil monetary penalties
   42 U.S.C. § 1320a-7b: Criminal penalties for action
    involving Federal health care programs
Anti-Kickback Statute (criminal)
   Knowingly and willfully
     Offer, pay, solicit or receive
     Any remuneration (in cash or in kind)
     To induce (or, in exchange for)
     The purchasing, ordering, or recommending of
      any good or service reimbursable by the
      Medicare, Medicaid or other federally funded
      health care programs
     Penalties: up to 5 years imprisonment, $25,000
      fine, or both
Stark Law (civil)

   Physician (including immediate family members) with a financial
    relationship with an entity, may not refer Medicare or Medicaid
    patient to that entity, and entity may not bill for "designated health
    services." Penalties include refunding improper claims and CMPs
    of up to $15,000 per claim
   Designated Health Services:
      Lab                            -Parenteral, enteral nutrition
      PT                             -Prosthetics, orthotics
      OT                             -Home health services, supplies
      Radiology                      -Outpatient drugs
      Radiation therapy              -Inpt/Outpt hospital services
      DME
Health Care Reform – Patient Protection
       and Affordable Care Act
             (“PPACA”)
    Oversight and enforcement increased, including:
       Fraud enforcement funding: additional $10 million
        yearly for years 2011 - 2020; $250 million over
        years 2011 - 2016
       Subpoena and testimony powers expanded for HHS
        and OIG
       Medicaid exclusions expanded: states must terminate
        provider excluded by Medicare or another state;
       Medicaid exclusion for failure to repay
        overpayments
PPACA Expansion of
Oversight and Enforcement

 Anti-Kickback intention standard eased;
  Stark self-disclosure expectations increased

 Provider enrollment: program participation
  screenings depending on “low”, “moderate”
  or “high” risk levels
II. Exposure: Acquired Conditions
          Payment Rules
Emergence of "Value Based
              Purchasing"
   Current Medicare payment system: consumption and
    quantity of care
   Center of Medicare and Medicaid Services (CMS)
      transforming Medicare from passive to active
       purchaser
   Goal: increase quality, avoid unnecessary costs
   VBP drivers: Congress, MedPAC and IOM reports,
    private sector
   Medicare Trust Fund solvency
Emergence of “Value-Based
              Purchasing”

   Value-Based Purchasing Initiatives
     Hospital Pay for Reporting
     Hospital VBP Plan
     VBP Nursing Home Demonstration
     VBP programs will affect home health,
      physicians & other providers
   Against VBP backdrop, HAC rules emerged
Legal Basis of HAC Payment Rules


   Deficit Reduction Act of 2005, Section 5001(c)

   Required CMS to select at least two conditions:
     High cost, high volume, or both
     Assigned to higher-paying DRG if present as
      secondary diagnosis
     Reasonably prevented through using evidence-
      based guidelines
Legal Basis of HAC Payment Rules
   Deficit Reduction Act
      October 1, 2007: Hospitals required to submit
       claims data indicating whether diagnoses are
       "present on admission"
      October 1, 2008: No payment for care associated
       with Hospital Acquired Condition (“Never
       Event”) unless identified as present on
       admission
   Medicare hospital payment regulations specify
    Hospital Acquired Conditions and include "Never
    Events"
Initial Hospital Acquired Conditions,
       including "Never Events"

   Object left in body after surgery*
   Air embolism*
   Blood incompatibility*
   Catheter-associated urinary tract infection
   Decubitus ulcers
   Vascular catheter-associated infection

* “Never Events”
Initial Hospital Acquired Conditions
                   (cont.)

   Surgical site infection-mediastinitis after CABG
   Falls-specific trauma codes
   Extreme manifestations of poor glycemic control
   Surgical infection post certain orthopedic, bariatric
    surgeries
   DVT/PE post hip, knee replacement surgeries
Acquired Conditions and Health
              Reform: Medicare

   PPACA requires Secretary of HHS to study expansion
    of Medicare HAC regulations to
       Rehab hospitals
       Long-term acute care hospitals
       Hospital outpatient departments
       Skilled nursing facilities
       Others
   Report due to Congress by January 1, 2012
   Impact on quality, safety and cost of care
Acquired Conditions and Health
              Reform: Medicaid
   By July 1, 2011, PPACA requires state Medicaid
    programs to ensure that Medicaid payments are not
    made for conditions covered by Medicare HAC policy
   Certain Medicare HACs may be excluded if
    inapplicable to Medicaid populations
   February 17, 2011 proposed regulations
       “Provider-Preventable Conditions,” “Other Provider-
        Preventable Conditions”
       Could have reasonably been prevented through
        application of evidence-based guidelines
       Not limited to inpatient hospital settings
III. Exposure: Recovery Audit
  Contractor (RAC) Program
The RAC Program: Background

              Congressional Authority

   Medicare Prescription Drug Improvement and
    Modernization Act of 2003
     Directed establishment of demonstration
      program

   Tax Relief and Health Care Act of 2006
      Expanded claims RAC nationwide in 2010
The RAC Program: Key Features
   To identify improper payments made on claims
    for health care services provided to Medicare
    beneficiaries

   RAC Program is separate from/addition to existing
    processes for identifying overpayments by
    Medicare Affiliated Contractors (MACs)
The RAC Program: Key Features

   Two types of RACs
      Medicare Secondary Payer (MSP) RACs
      Claims RACs
   Affected providers include physicians, hospitals,
    SNFs, inpatient rehab, clinical labs, DME
   Medicare Advantage and Part D claims excluded
    from RAC review
   RACs receive contingency payments
RAC Program: Key Features

   RAC Review Process
       RAC review of claims data files
       Look-back period—Was 4 years in
        demonstration, now 3 years
       RACs may not review claims already reviewed,
        ongoing post-payment medical review claims,
        claims under fraud, criminal investigations
       Automated and Complex claims reviews
RAC Collection / Appeal Process

   Collection same as for Medicare contractor –
    identified overpayments
   Recoupment via offset unless provider submits check
    or valid appeal
   Appeal timeframes
    http://www.cms.gov/MLNproducts/downloads/
      MedicareAppealsProcess.pdf
Medicaid RAC Program
   PPACA requires states to contract with one or more
    RACS by December 31, 2010 (postponed)
   November 10, 2010 proposed regulations; new
    implementation date with final regulations
   State plan amendments due December 31, 2010
   Contingency fee payments (like Medicare RACS)
   State may use current Medicaid appeals process for
    RAC appeals
   State variations likely – look-back periods, types of
    claims reviewed
IV. Exposure: Health Information
       Privacy & Security
HIPAA Basics
 HIPAA    applies to Covered Entities
 "Covered Entities"
    Health care providers who transmit electronic
     standard transactions
    Health plans, including employer sponsored
     health benefits plans
    Health care clearinghouses: entities that process
     electronic data formats
HIPAA Basics

 HIPAA    also regulates "Business Associates"
  (effective February 17, 2010)
 A Business Associate performs functions or
  activities on behalf of a Covered Entity and uses or
  accesses PHI to do so.
 Business Associate functions include management,
  administrative, legal, actuarial, accounting and
  consulting
 Business Associate Agreement required between
  Covered Entity and Business Associate
HIPAA Privacy Rule Basics
 Basic  Rule
    No use or disclosure of PHI by Covered Entities
     unless authorized by the individual or permitted
     by the Privacy Rule
 Permitted uses/disclosures include
    For treatment, payment and health care
     operations purposes ("TPO")
    To the patient
    Specific exceptions list in the regulations
HIPAA Enforcement Basics
 HHS    Office of Civil Rights ("OCR") enforces
  HIPAA privacy and security regulations
 Statutory civil monetary and criminal penalties for
  HIPAA violations
 No private right of action under HIPAA, however
  State Attorneys General now authorized to bring
  suit, in addition to U.S. Attorneys
 OIG Work Plan targets hospital security controls
  for PHI on portable devices, privacy and breach
  response compliance
HIPAA Enforcement
   Resolution Agreements: (Providence Health,
    CVS/Caremark, Mass General)
   HIPAA prosecutions
     Criminal cases involving the use/disclosure of
      PHI for personal gain (Gibson, Ferrer and
      Machado, Ramirez)
     Criminal cases involving inappropriate access
      to PHI (Zhou, Holland, Miller and Griffen)
     HITECH clarified that individuals may be
      prosecuted
HIPAA Updated by HITECH
   American Recovery and Reinvestment Act of
    2009, February 17, 2009 (ARRA)
   Title XIII, Health Information Technology for
    Economic and Clinical Health Act (HITECH)
      Bureaucracy for national EHR infrastructure to
       set EHR standards, administer EHR stimulus
       funding
      Medicare and Medicaid reimbursement
       methods to incent EHR adoption
      New HIPAA privacy and security requirements
HITECH: New Federal breach
       notification requirements
 Prior to HITECH, covered entities were not
  required to notify patients of breaches of PHI,
  unless required by state law
 HITECH breach regulations 45 C.F.R. 164.400-414
 Effective 9/23/09, covered entities must notify
  patients whose unsecured PHI has been breached
 HIPAA business associate must notify covered
  entity when unsecured PHI has been breached
Illinois Personal Information
                Protection Act
 Notice to IL residents of unauthorized acquisition
  of computerized data that compromises the
  security, confidentiality or integrity of personal
  information
 Personal information: first initial or name/last name
  with SSN# or driver’s license #/state ID # or
  account/credit/debit card # with or without access
  code
 Notice must be made in the “most expedient time
  possible” and “without unreasonable delay”
"Breach" under HITECH


   Not all impermissible uses or disclosures are
    breaches
   "Breach" = unauthorized acquisition, access, use
    or disclosure of PHI which compromises the
    security or privacy of the information
   "Compromises" = poses a significant risk of
    financial, reputational or other harm to the
    individual
Breach risk assessment

   Must be performed in order to determine whether
    there is a significant risk of harm
   Must be documented, as covered entity's (and
    business associate's) burden of proof includes
    demonstrating that a use or disclosure was not a
    breach
Breach risk assessment under
                   HITECH
   Data files containing
     Patient names


       Patient names and social security numbers

       Patient names in files labeled "CHF“

       Health plan identification numbers

       Claims information including procedure codes
Breach investigations and Business
            Associates
 HITECH    requires
   BA to notify CE of breach of unsecured PHI
   Notice shall include, to extent possible,
    identification of each individual affected
   BA to provide CE with any other available
    information that CE is required to include in
    individual notice
   Notice must be provided without unreasonable
    delay and in no case later that 60 days after
    discovery of breach
HITECH Breach Notice Requirements
                   Individual Notice

   To each individual whose unsecured PHI has
    been breached
   If 10 or more individuals for whom there is
    insufficient contact information, substitute notice
    required
      Conspicuous website posting for 90 days
      Notice in major print or broadcast media
      Toll-free number active for 90 days
   To next of kin or personal representative of
    deceased individuals, if address known
HITECH Breach Notice Requirements
                     Individual Notice
   "Without unreasonable delay," but no later than 60
    days after discovery of breach
   In writing, by first class mail, unless individual as
    agreed in advance to email communications
   By telephone, if possibility of imminent misuse of
    PHI
   Law enforcement delay: Upon written or oral
    statement by law enforcement official that notice
    or posting would impede investigation
Content of Individual Notice
   Description of what happened, date of discovery
   Types of PHI involved
   Steps individual can take to protect from potential
    harm
   Description of what health plan is doing to
    investigate, mitigate losses and protect against
    further breaches
   Contact for questions, including a toll-free phone
    number
HITECH Breach Notice Requirements

 Notice to the media
   Breach involving more than 500 residents of a
    state or jurisdiction
   Prominent media outlets serving the state or
    jurisdiction
   Same content and timing requirements as for
    individual notice
   Press release indicated by OCR as expected form
    of media notice
HITECH Breach Notice Requirements
 Notice to the Secretary
   If breach involves 500 or more individuals,
    notice to be provided contemporaneously with
    individual notice
   If breach involves fewer than 500 individuals,
    log must be maintained and reported annually
    not later than 60 days after end of each calendar
    year
 Forreports of 500 or more, expect indication of
 further follow-up by OCR
Additional requirements
   Policies and procedures for compliance with
    HITECH breach notice requirements

   Training workforce regarding breach policies and
    procedures

   Sanctions for non-compliance
Breach response realities
   Have ready to go
     Data breach reporting policies and procedures,
      consistent with HIPAA policies and training
      requirements
     Data breach response policy, pre-selected
      response team
     Risk assessment documentation template
     Template notice letter
     Data breach liability policy?
V. Exposure: Excluded Individuals
Excluded Individuals
   Bases for exclusion from Medicare or Medicaid
    program participation
       Sexual assault
       Patient abuse
       Failure to repay HEAL loans
       Criminal convictions related to program
       Criminal convictions related to controlled substances
       Licensure issues
Excluded Individuals
   No Medicare, Medicaid or any other Federal health
    care program payment may be made for items or
    services (1) furnished by an excluded individual,
    or (2) directed or prescribed by an excluded
    physician (itemized claims, cost reports, fee
    schedules or PPS payments)
   Civil monetary penalties (CMPs) may be imposed
    for submission of improper claims, including
    claims submitted by an excluded individual
Excluded Individuals
    OIG Special Advisory Bulletin
     Prohibition extends to administration and
       management services not directly related to
       patient care
     Prohibition continues to apply even if individual
       changes health professions while excluded
     No Federal program payment may be made to
       cover individual’s salary, expenses or benefits
       regardless of whether direct patient care is
       provided
Excluded Individuals
   OIG Special Advisory Bulletin

       To avoid CMP liability, check OIG List of
        Excluded Individuals/Entities prior to hiring or
        contracting and periodically

       Check Excluded Parties List System
        (maintained by the GSA) also

       State Medicaid list
Compliance Programs – Today Voluntary
    OIG Compliance Guidance for Nursing Facilities
     (2000; Supplemental guidance 2008)
     Quality Care (staffing, training)
     Accurate claims (upcoding, therapy services,
        excluded individuals, anti-kickback
     Involvement of board of directors and senior
        officers
     Annual reviews
     Self-reporting
Compliance Programs – Soon Mandatory

    PPACA Section 6102
     Medicare SNFs and Medicaid NFs must have
       compliance and ethics program with 3 years of
       PPACA enactment
     HHS and OIG to establish regulations
     Organizations with 5 or more facilities must
       have more formal program with written policies
       and procedures
Compliance Programs – Soon Mandatory

    SNF/NF compliance program – reasonably
     designed, implemented and enforced to be
     generally effective in preventing and detecting civil
     criminal and administrative violations, as well as
     promoting quality of care
    Required components
     Compliance procedures to guide employees
     Assigned compliance responsibilities to senior
        individuals within operating organizations
Compliance Programs – Soon Mandatory

    Required components (cont.)
     Restriction of at-risk individuals from
       involvement with compliance responsibilities
     Effective communications
     Auditing and monitoring
     Appropriate disciplinary measures, including for
       failing to detect offenses
     Appropriate response mechanisms
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Life services network 2011 presentation

  • 1. Life Services Network 2011 Annual Meeting March 23 – 25 Health Care Regulatory Exposures: An Evolving Landscape Katherine M. Keefe Chair, Health Care Practice Dilworth Paxson LLP Christopher M. Breck, CIC, ARM Managing Director of Healthcare Alper Services, LLC Sharon M. Livas Sr. Vice President – Healthcare Alper Services, LLC
  • 2. Health Care Regulatory Exposures: An Evolving Landscape Illinois Workers Compensation Reform Christopher M. Breck, CIC, ARM Managing Director of Healthcare Alper Services, LLC Sharon M. Livas Sr. Vice President – Healthcare Alper Services, LLC
  • 3. Illinois Talks of Workers’ Compensation Reform
  • 4. Illinois Talks of Workers’ Compensation Reform Stakeholders  Dr’s  Business  Labor  Lawyers  Workers  Politicians
  • 5. Illinois Talks of Workers’ Compensation Reform Most Expensive Change in Rank States 2008 vs. 2010  Montana 2-1  Alaska 1- 2  Illinois 10 -3  Oklahoma 9-4  California 13 - 5  Connecticut 20 - 6  New Jersey 16 - 7
  • 6. Illinois Talks of Workers’ Compensation Reform Current Causation  Accident need only be a causative factor  May be based on a sequence of events without medical testimony  Aggravation of pre-existing condition
  • 7. Illinois Talks of Workers’ Compensation Reform Proposed Causation  Change work related condition to be “caused” by work as PRIMARY factor  Current indefensible standard allowing work to be “a” cause not “the” cause.
  • 8. Illinois Talks of Workers’ Compensation Reform Current Choice of Medical Care  Employee has choice of up to 2 treating physicians and referrals Proposed Choices for Medical Care  1st choice to Employer; 2nd choice to Employee
  • 9. Illinois Talks of Workers’ Compensation Reform Current AMA Standards  Not applied in IL  38 states recognize guidelines Proposed AMA Standards  Require objective findings of disability based on AMA guidelines
  • 10. Illinois Talks of Workers’ Compensation Reform Current Wage Differential  Lifetime benefit requires physical rather than economic change  Unlimited Number of awards  Based on Maximum state average weekly wage
  • 11. Illinois Talks of Workers’ Compensation Reform Proposed Wage Differential  Cap until Age 67 or 5 years post injury  Allow modification based on a material increase in earnings  Cap benefit at max PPD rate
  • 12. Illinois Talks of Workers’ Compensation Reform Current Intoxication Defense  There is none
  • 13. Illinois Talks of Workers’ Compensation Reform Proposed Intoxication Defense  Create rebuttable presumption that there will be NO benefits if alcohol level is . 08 or above or any other illegal substance OR refuses testing
  • 14. Illinois Talks of Workers’ Compensation Reform Current Fee Schedule  Medical Fee Schedule 2nd highest in the country (WCRI)
  • 15. Illinois Talks of Workers’ Compensation Reform Proposed Schedule  Reduce 15-20%  Provide reimbursement for out of state procedures, treatments and supplies  Cap reimbursements for Implants at cost plus of 25%
  • 16. Illinois Talks of Workers’ Compensation Reform REFORM + EARLY INTERVENTION + SAFETY TRAINING + HIRING PRACTICES = LOWER COSTS AND HEALTHY EMPLOYEES
  • 17. Illinois Talks of Workers’ Compensation Reform  How does IL rank in costs?  If my blood alcohol is .06, will my Work Comp clam be paid?  What year were the last reforms made to the system?
  • 18. Illinois Talks of Workers’ Compensation Reform  Why have medical costs increased faster in workers compensation vs. health plans?  What can you personally do to help reforms be adopted in Illinois?
  • 19. Health Care Regulatory Exposures: An Evolving Landscape Enforcement Overview Specific areas of regulatory risk Acquired conditions RAC Privacy Excluded Individuals Compliance Programs
  • 21. Overview of the Health Care Industry: Enforcement Agencies  HHS Centers for Medicare & Medicaid Services (CMS)  Food and Drug Administration (FDA)  Office of Inspector General (OIG)  Department of Justice (DOJ)  Federal Bureau of Investigation (FBI)  HHS Office of Civil Right (OCR)  State Attorneys General  Private Litigants
  • 22. Centers for Medicare & Medicaid Services (CMS)  Within HHS, administers Medicare, Medicaid, State Children's Health Insurance Program (SCHIP), HIPAA (transactions) CLIA, other programs  90 million beneficiaries  $650 billion budget  "Stewards accountable for resources and effectiveness"
  • 23. Office of Inspector General (OIG)  OIG mandated by law to protect integrity of HHS programs, and health and welfare of program beneficiaries  OIG responsible to report to Secretary of HHS and Congress problems and recommendations  OIG duties carried out through a nationwide network of audits, investigations and inspections
  • 24. OIG Initiatives  Annual work plans  Self-disclosure protocol  Recently refined  Good faith disclosures  Imposes Corporate Integrity/Compliance Agreements  Compliance Program Guidance  Provider-specific (i.e., hospital, home health, lab, DME)  Nursing facility guidance
  • 25. OIG 2011 Work Plan  Senior services focus includes:  Nursing home payment and oversight  Assessment of atypical antipsychotic drugs  Nursing home resident hospitalizations  Criminal background checks for nursing home employees  Emergency preparedness
  • 26. FALSE CLAIMS ACT  31 U.S.C. §§ 3729-2733 imposes civil liability against a person or entity that:  Knowingly (can be shown by reckless disregard for the truth)  Presents a false claim for payment, or  Uses a false record or statement to get a claim paid or approved, or causes a third party to do either of above  Treble damage award  Additional penalty for each claim between $5,000 and $11,000.
  • 27. FCA Whistleblower ("Qui Tam") Provisions  Private citizen whistleblower ("relator") files action and submits to U.S. Attorney for review  Government investigates and decides whether to intervene  If government does not intervene, relator may pursue action on his/her own, in the shoes of the government.  Relator may receive  up to 25% of award if government intervenes  30% if government does not intervene and relator pursues
  • 28. Majority of False Claim Actions Come from Whistleblowers  Whistleblowers are everywhere  From lower level employees to professionals or executive employees
  • 29. Computation of FCA Judgment  $334 million judgment (3/07) against AmeriGroup health plan  Illinois hired Amerigroup to administer Medicaid managed care program  Amerigroup alleged to have avoided pregnant women and others with expensive health conditions  False Claims Action  Whistleblower was former head of government relations; received between 15% and 25% of award.  Judgment Total: Jury award: $48 million in damages, trebled (x3) = $144 million, judge assessed penalty of $10,500 on each of 18,130 claims = $190,365,000 TOTAL: $334 million.  Other costs – employee time and lawyers' fees
  • 30. Social Security Act Relevant Provisions  42 U.S.C. § 1320a-7: Exclusion of individuals and entities from participation in Medicare and State health care programs  42 U.S.C. § 1320a-7a: Civil monetary penalties  42 U.S.C. § 1320a-7b: Criminal penalties for action involving Federal health care programs
  • 31. Anti-Kickback Statute (criminal)  Knowingly and willfully  Offer, pay, solicit or receive  Any remuneration (in cash or in kind)  To induce (or, in exchange for)  The purchasing, ordering, or recommending of any good or service reimbursable by the Medicare, Medicaid or other federally funded health care programs  Penalties: up to 5 years imprisonment, $25,000 fine, or both
  • 32. Stark Law (civil)  Physician (including immediate family members) with a financial relationship with an entity, may not refer Medicare or Medicaid patient to that entity, and entity may not bill for "designated health services." Penalties include refunding improper claims and CMPs of up to $15,000 per claim  Designated Health Services:  Lab -Parenteral, enteral nutrition  PT -Prosthetics, orthotics  OT -Home health services, supplies  Radiology -Outpatient drugs  Radiation therapy -Inpt/Outpt hospital services  DME
  • 33. Health Care Reform – Patient Protection and Affordable Care Act (“PPACA”)  Oversight and enforcement increased, including:  Fraud enforcement funding: additional $10 million yearly for years 2011 - 2020; $250 million over years 2011 - 2016  Subpoena and testimony powers expanded for HHS and OIG  Medicaid exclusions expanded: states must terminate provider excluded by Medicare or another state;  Medicaid exclusion for failure to repay overpayments
  • 34. PPACA Expansion of Oversight and Enforcement  Anti-Kickback intention standard eased; Stark self-disclosure expectations increased  Provider enrollment: program participation screenings depending on “low”, “moderate” or “high” risk levels
  • 35. II. Exposure: Acquired Conditions Payment Rules
  • 36. Emergence of "Value Based Purchasing"  Current Medicare payment system: consumption and quantity of care  Center of Medicare and Medicaid Services (CMS)  transforming Medicare from passive to active purchaser  Goal: increase quality, avoid unnecessary costs  VBP drivers: Congress, MedPAC and IOM reports, private sector  Medicare Trust Fund solvency
  • 37. Emergence of “Value-Based Purchasing”  Value-Based Purchasing Initiatives  Hospital Pay for Reporting  Hospital VBP Plan  VBP Nursing Home Demonstration  VBP programs will affect home health, physicians & other providers  Against VBP backdrop, HAC rules emerged
  • 38. Legal Basis of HAC Payment Rules  Deficit Reduction Act of 2005, Section 5001(c)  Required CMS to select at least two conditions:  High cost, high volume, or both  Assigned to higher-paying DRG if present as secondary diagnosis  Reasonably prevented through using evidence- based guidelines
  • 39. Legal Basis of HAC Payment Rules  Deficit Reduction Act  October 1, 2007: Hospitals required to submit claims data indicating whether diagnoses are "present on admission"  October 1, 2008: No payment for care associated with Hospital Acquired Condition (“Never Event”) unless identified as present on admission  Medicare hospital payment regulations specify Hospital Acquired Conditions and include "Never Events"
  • 40. Initial Hospital Acquired Conditions, including "Never Events"  Object left in body after surgery*  Air embolism*  Blood incompatibility*  Catheter-associated urinary tract infection  Decubitus ulcers  Vascular catheter-associated infection * “Never Events”
  • 41. Initial Hospital Acquired Conditions (cont.)  Surgical site infection-mediastinitis after CABG  Falls-specific trauma codes  Extreme manifestations of poor glycemic control  Surgical infection post certain orthopedic, bariatric surgeries  DVT/PE post hip, knee replacement surgeries
  • 42. Acquired Conditions and Health Reform: Medicare  PPACA requires Secretary of HHS to study expansion of Medicare HAC regulations to  Rehab hospitals  Long-term acute care hospitals  Hospital outpatient departments  Skilled nursing facilities  Others  Report due to Congress by January 1, 2012  Impact on quality, safety and cost of care
  • 43. Acquired Conditions and Health Reform: Medicaid  By July 1, 2011, PPACA requires state Medicaid programs to ensure that Medicaid payments are not made for conditions covered by Medicare HAC policy  Certain Medicare HACs may be excluded if inapplicable to Medicaid populations  February 17, 2011 proposed regulations  “Provider-Preventable Conditions,” “Other Provider- Preventable Conditions”  Could have reasonably been prevented through application of evidence-based guidelines  Not limited to inpatient hospital settings
  • 44. III. Exposure: Recovery Audit Contractor (RAC) Program
  • 45. The RAC Program: Background Congressional Authority  Medicare Prescription Drug Improvement and Modernization Act of 2003  Directed establishment of demonstration program  Tax Relief and Health Care Act of 2006  Expanded claims RAC nationwide in 2010
  • 46. The RAC Program: Key Features  To identify improper payments made on claims for health care services provided to Medicare beneficiaries  RAC Program is separate from/addition to existing processes for identifying overpayments by Medicare Affiliated Contractors (MACs)
  • 47. The RAC Program: Key Features  Two types of RACs  Medicare Secondary Payer (MSP) RACs  Claims RACs  Affected providers include physicians, hospitals, SNFs, inpatient rehab, clinical labs, DME  Medicare Advantage and Part D claims excluded from RAC review  RACs receive contingency payments
  • 48. RAC Program: Key Features  RAC Review Process  RAC review of claims data files  Look-back period—Was 4 years in demonstration, now 3 years  RACs may not review claims already reviewed, ongoing post-payment medical review claims, claims under fraud, criminal investigations  Automated and Complex claims reviews
  • 49. RAC Collection / Appeal Process  Collection same as for Medicare contractor – identified overpayments  Recoupment via offset unless provider submits check or valid appeal  Appeal timeframes http://www.cms.gov/MLNproducts/downloads/ MedicareAppealsProcess.pdf
  • 50. Medicaid RAC Program  PPACA requires states to contract with one or more RACS by December 31, 2010 (postponed)  November 10, 2010 proposed regulations; new implementation date with final regulations  State plan amendments due December 31, 2010  Contingency fee payments (like Medicare RACS)  State may use current Medicaid appeals process for RAC appeals  State variations likely – look-back periods, types of claims reviewed
  • 51. IV. Exposure: Health Information Privacy & Security
  • 52. HIPAA Basics  HIPAA applies to Covered Entities  "Covered Entities"  Health care providers who transmit electronic standard transactions  Health plans, including employer sponsored health benefits plans  Health care clearinghouses: entities that process electronic data formats
  • 53. HIPAA Basics  HIPAA also regulates "Business Associates" (effective February 17, 2010)  A Business Associate performs functions or activities on behalf of a Covered Entity and uses or accesses PHI to do so.  Business Associate functions include management, administrative, legal, actuarial, accounting and consulting  Business Associate Agreement required between Covered Entity and Business Associate
  • 54. HIPAA Privacy Rule Basics  Basic Rule  No use or disclosure of PHI by Covered Entities unless authorized by the individual or permitted by the Privacy Rule  Permitted uses/disclosures include  For treatment, payment and health care operations purposes ("TPO")  To the patient  Specific exceptions list in the regulations
  • 55. HIPAA Enforcement Basics  HHS Office of Civil Rights ("OCR") enforces HIPAA privacy and security regulations  Statutory civil monetary and criminal penalties for HIPAA violations  No private right of action under HIPAA, however State Attorneys General now authorized to bring suit, in addition to U.S. Attorneys  OIG Work Plan targets hospital security controls for PHI on portable devices, privacy and breach response compliance
  • 56. HIPAA Enforcement  Resolution Agreements: (Providence Health, CVS/Caremark, Mass General)  HIPAA prosecutions  Criminal cases involving the use/disclosure of PHI for personal gain (Gibson, Ferrer and Machado, Ramirez)  Criminal cases involving inappropriate access to PHI (Zhou, Holland, Miller and Griffen)  HITECH clarified that individuals may be prosecuted
  • 57. HIPAA Updated by HITECH  American Recovery and Reinvestment Act of 2009, February 17, 2009 (ARRA)  Title XIII, Health Information Technology for Economic and Clinical Health Act (HITECH)  Bureaucracy for national EHR infrastructure to set EHR standards, administer EHR stimulus funding  Medicare and Medicaid reimbursement methods to incent EHR adoption  New HIPAA privacy and security requirements
  • 58. HITECH: New Federal breach notification requirements  Prior to HITECH, covered entities were not required to notify patients of breaches of PHI, unless required by state law  HITECH breach regulations 45 C.F.R. 164.400-414  Effective 9/23/09, covered entities must notify patients whose unsecured PHI has been breached  HIPAA business associate must notify covered entity when unsecured PHI has been breached
  • 59. Illinois Personal Information Protection Act  Notice to IL residents of unauthorized acquisition of computerized data that compromises the security, confidentiality or integrity of personal information  Personal information: first initial or name/last name with SSN# or driver’s license #/state ID # or account/credit/debit card # with or without access code  Notice must be made in the “most expedient time possible” and “without unreasonable delay”
  • 60. "Breach" under HITECH  Not all impermissible uses or disclosures are breaches  "Breach" = unauthorized acquisition, access, use or disclosure of PHI which compromises the security or privacy of the information  "Compromises" = poses a significant risk of financial, reputational or other harm to the individual
  • 61. Breach risk assessment  Must be performed in order to determine whether there is a significant risk of harm  Must be documented, as covered entity's (and business associate's) burden of proof includes demonstrating that a use or disclosure was not a breach
  • 62. Breach risk assessment under HITECH  Data files containing  Patient names  Patient names and social security numbers  Patient names in files labeled "CHF“  Health plan identification numbers  Claims information including procedure codes
  • 63. Breach investigations and Business Associates  HITECH requires  BA to notify CE of breach of unsecured PHI  Notice shall include, to extent possible, identification of each individual affected  BA to provide CE with any other available information that CE is required to include in individual notice  Notice must be provided without unreasonable delay and in no case later that 60 days after discovery of breach
  • 64. HITECH Breach Notice Requirements Individual Notice  To each individual whose unsecured PHI has been breached  If 10 or more individuals for whom there is insufficient contact information, substitute notice required  Conspicuous website posting for 90 days  Notice in major print or broadcast media  Toll-free number active for 90 days  To next of kin or personal representative of deceased individuals, if address known
  • 65. HITECH Breach Notice Requirements Individual Notice  "Without unreasonable delay," but no later than 60 days after discovery of breach  In writing, by first class mail, unless individual as agreed in advance to email communications  By telephone, if possibility of imminent misuse of PHI  Law enforcement delay: Upon written or oral statement by law enforcement official that notice or posting would impede investigation
  • 66. Content of Individual Notice  Description of what happened, date of discovery  Types of PHI involved  Steps individual can take to protect from potential harm  Description of what health plan is doing to investigate, mitigate losses and protect against further breaches  Contact for questions, including a toll-free phone number
  • 67. HITECH Breach Notice Requirements  Notice to the media  Breach involving more than 500 residents of a state or jurisdiction  Prominent media outlets serving the state or jurisdiction  Same content and timing requirements as for individual notice  Press release indicated by OCR as expected form of media notice
  • 68. HITECH Breach Notice Requirements  Notice to the Secretary  If breach involves 500 or more individuals, notice to be provided contemporaneously with individual notice  If breach involves fewer than 500 individuals, log must be maintained and reported annually not later than 60 days after end of each calendar year  Forreports of 500 or more, expect indication of further follow-up by OCR
  • 69. Additional requirements  Policies and procedures for compliance with HITECH breach notice requirements  Training workforce regarding breach policies and procedures  Sanctions for non-compliance
  • 70. Breach response realities  Have ready to go  Data breach reporting policies and procedures, consistent with HIPAA policies and training requirements  Data breach response policy, pre-selected response team  Risk assessment documentation template  Template notice letter  Data breach liability policy?
  • 71. V. Exposure: Excluded Individuals
  • 72. Excluded Individuals  Bases for exclusion from Medicare or Medicaid program participation  Sexual assault  Patient abuse  Failure to repay HEAL loans  Criminal convictions related to program  Criminal convictions related to controlled substances  Licensure issues
  • 73. Excluded Individuals  No Medicare, Medicaid or any other Federal health care program payment may be made for items or services (1) furnished by an excluded individual, or (2) directed or prescribed by an excluded physician (itemized claims, cost reports, fee schedules or PPS payments)  Civil monetary penalties (CMPs) may be imposed for submission of improper claims, including claims submitted by an excluded individual
  • 74. Excluded Individuals  OIG Special Advisory Bulletin  Prohibition extends to administration and management services not directly related to patient care  Prohibition continues to apply even if individual changes health professions while excluded  No Federal program payment may be made to cover individual’s salary, expenses or benefits regardless of whether direct patient care is provided
  • 75. Excluded Individuals  OIG Special Advisory Bulletin  To avoid CMP liability, check OIG List of Excluded Individuals/Entities prior to hiring or contracting and periodically  Check Excluded Parties List System (maintained by the GSA) also  State Medicaid list
  • 76. Compliance Programs – Today Voluntary  OIG Compliance Guidance for Nursing Facilities (2000; Supplemental guidance 2008)  Quality Care (staffing, training)  Accurate claims (upcoding, therapy services, excluded individuals, anti-kickback  Involvement of board of directors and senior officers  Annual reviews  Self-reporting
  • 77. Compliance Programs – Soon Mandatory  PPACA Section 6102  Medicare SNFs and Medicaid NFs must have compliance and ethics program with 3 years of PPACA enactment  HHS and OIG to establish regulations  Organizations with 5 or more facilities must have more formal program with written policies and procedures
  • 78. Compliance Programs – Soon Mandatory  SNF/NF compliance program – reasonably designed, implemented and enforced to be generally effective in preventing and detecting civil criminal and administrative violations, as well as promoting quality of care  Required components  Compliance procedures to guide employees  Assigned compliance responsibilities to senior individuals within operating organizations
  • 79. Compliance Programs – Soon Mandatory  Required components (cont.)  Restriction of at-risk individuals from involvement with compliance responsibilities  Effective communications  Auditing and monitoring  Appropriate disciplinary measures, including for failing to detect offenses  Appropriate response mechanisms