THE BRODY SCHOOL OF MEDICINE NEW EMPLOYEE ORIENTATION COMMITMENT TO COMPLIANCE: INTRODUCTION TO THE BSOM COMPLIANCE PROGRAM

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THE BRODY SCHOOL OF MEDICINENEW EMPLOYEE
ORIENTATIONCOMMITMENT TO COMPLIANCE
INTRODUCTION TO THE BSOM COMPLIANCE PROGRAM

• Joan A. Kavuru, JD, RN
• Director of Compliance, BSOM

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What is the BSOM compliance program?

• A program designed to promote institutional and
  individual compliance with applicable laws,
  regulations, and University policies.
• Controls that are established to prevent, detect,
  and resolve illegal, unethical or other actions
  that are not in compliance with University policy.

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Why have a compliance program?

• Imperative to prevent, detect, and correct
  potential violations of law, regulations, and
  policies of ECU
• Support the integrity of the Schools mission
  Patient care, education, and research
• Institutional reputation
• Ability to preserve resources to further mission
• Industry standard
• Evolution of compliance program development in
  health care
• Federal Sentencing Guidelines and OIG guidance

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Who implements the compliance program?

• Office of Compliance at BSOM
• Director of Compliance, Joan A. Kavuru, JD, RN
• Billing Compliance Manager, Charlotte Price,
  RHIA, CCS-P, CPC
• Coding Analyst A. Michele Lang
• Program Assistant Debra Duncan
• Compliance Committee
• Chairperson, Nicholas Benson, M.D., M.B.A.,
  Senior Associate Dean for Operations
• Members include various representatives from
  BSOM, the University, and PCMH
• Individual Employees at BSOM
• Most important resource

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Code of Conduct

• Standards for conduct at BSOM
• Must read and sign attestation for Code of
  Conduct
• Individual commitment to understanding and
  following the rules and ethical standards
• Condition of employment

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Areas of Focus

• Billing and Reimbursement for Patient Care
  Services
• Highly regulated by Medicare and Medicaid
• Commercial payor requirements
• ECU Billing and Documentation Standards
• Provider billing monitoring
• Education
• New employee education
• Ongoing education for providers
• Ensure highest integrity in our billing practices

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Areas of Focus

• Federal Anti-kickback Statute
• Forbids any knowing and willful conduct involving
  the solicitation, receipt, offer or payment of
  any kind of remuneration in return for referring
  an individual or for recommending or arranging
  the purchase, lease or ordering of an item or
  service that may be paid for under a federal
  health care program.
• Criminal and civil liability for failure to
  comply.

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Areas of Focus

• Federal Anti-kickback Statute
• Tenet Healthcare 900 million settlement Part
  of settlement resulted from hidden kickbacks in
  physician relocation agreements.
• Serono 567 million settlement Serono admitted
  to providing physicians all-expense paid trips to
  France to attend conference if wrote 30 new
  prescriptions for a certain drug.
• Fresenius Medical Care 385 million settlement
  Involved kickbacks to medical directors.

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Areas of Focus

• Federal Prohibition on Physician Self-Referral
  (Stark Law)
• Prohibits referrals between a physician and an
  entity with which that physician has a financial
  interest
• Only certain designated health services subject
  to the Stark Law
• Civil liability for failure to comply
• Stark Safe Harbor Regulations
• Rapid City Regional Hospital 6.5 million
  settlement Provided below-market lease of space
  to physician group.

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Areas of Focus

• Research Compliance
• Human Subject Protections
• Clinical Trial Billing Compliance
• Rush University Medical Center self-disclosed
  clinical trial billing problems resulting in 1
  million settlement with OIG inadvertently billed
  Medicare for services provided during cancer
  therapy research studies that were not
  reimbursable by Medicare
• Must not bill Medicare for study
  services/supplies already paid for by study
  sponsor

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Areas of Focus

• Research Compliance (contd)
• Time and Effort Reporting
• University of Alabama 3.39 million settlement
  Inflated percentage of work effort researchers
  devoted to projects to more quickly access grant
  money also siphoned off money to cover budget
  shortfalls in other areas and pay people who did
  not work on projects.

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Areas of Focus

• HIPAA Privacy and Security Rules
• University Privacy Officer responsible for
  implementation and day to day administration
• All privacy complaints should be directed to the
  University Interim Privacy Officer
• Office of Compliance provides oversight

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Areas of Focus

• Conflict of Interest Disclosures
• Annual Conflict of Interest Disclosure Forms
• Ongoing duty to report changes
• Notice of Intent to Engage in Outside Activities
  for Pay
• Proper disclosure maintains integrity of patient
  care and research

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False Claims Act

• False Claims Act (FCA) prohibits anyone from
  knowingly submitting a false or fraudulent
  claim for payment
• Knowingly means (i) actual knowledge (ii) acts
  in deliberate ignorance of the truth or falsity
  of the information or (iii) acts in reckless
  disregard of the truth or falsity of the
  information.
• No proof of specific intent to defraud is
  required liability is proven by evidence of
  deliberate ignorance or reckless disregard of
  truth of the claim

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False Claims Act

• Damages Triple damages and penalties of 5,500
  to 11,000 per false claim for submission or
  causing submission of false claim.
• False claims can result from actions such as
  billing for services not rendered, upcoding and
  bundling, kickbacks, lack of medical necessity,
  false certification.

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Qui Tam Actions

• The FCA allows a private person (a qui tam
  relator) to bring a civil action in the name of
  the United States.
• Qui tam relators share in any money recovered
  (including settlements).
• If government joins in action, relator is
  entitled to 15 to 25 of proceeds depending on
  relators contribution to case.
• If government does not join in action, court may
  award relator not less than 25 and not more than
  30 of proceeds.

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Reporting Incidents of Noncompliance

• Encouraged to use supervisors, administrators as
  the first line of reporting of any known
  incidents of noncompliance.
• BSOM Compliance Hotline
• Available 24 hours a day, 7 days a week
• Can be anonymous
• Toll free 1-866-515-4587
• No retaliation for good faith reporting of
  incidents of noncompliance.
• All good faith reports will be fully
  investigated.
• Confidentiality maintained to the fullest extent
  possible.

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Office of Compliance at BSOM

• Serves as a resource to all faculty and staff
• Contact information
• 744-5200
• kavuruj_at_ecu.edu