Download introduction to the bsom compliance program

THE BRODY SCHOOL OF MEDICINE
NEW EMPLOYEE ORIENTATION
COMMITMENT TO COMPLIANCE:
INTRODUCTION TO THE BSOM
COMPLIANCE PROGRAM
Joan A. Kavuru, JD, RN
Director of Compliance, BSOM
What is the BSOM compliance program?
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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.
Why have a compliance program?
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Imperative to prevent, detect, and correct
potential violations of law, regulations, and
policies of ECU
Support the integrity of the School’s mission:
Patient care, education, and research
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Institutional reputation
Ability to preserve resources to further mission
Industry standard
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Evolution of compliance program development in health care
Federal Sentencing Guidelines and OIG guidance
Who implements the compliance program?
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Office of Compliance at BSOM
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Compliance Committee
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Director of Compliance, Joan A. Kavuru, JD, RN
Billing Compliance Manager, Charlotte Price, RHIA, CCS-P, CPC (43388)
Coding Analyst: A. Michele Lang (43101)
Program Assistant: Debra Duncan (45200)
Members include various representatives from BSOM and the University
Individual Employees at BSOM
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Most important resource
Have a duty to report issues of concern; no retaliation if reports are made in good
faith
Code of Conduct
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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
Areas of Focus: Billing and
Reimbursement
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Billing and Reimbursement for Patient Care
Services
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Education
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Highly regulated by Medicare and Medicaid
Commercial payor requirements
ECU Billing and Documentation Standards
Provider billing monitoring
New employee education
Ongoing education for providers
Ensure highest integrity in our billing practices
Areas of Focus: Federal Anti-Kickback
Statute
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Federal Anti-Kickback Statute
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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.
Areas of Focus: Federal Anti-Kickback
Statute
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Federal Anti-kickback: Regulatory Safe Harbors
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Not a “per se” violation of law to be “outside” of a safe
harbor
Most important consideration is “fair market value”
Affects many physician contractual relationships
Leases with referral sources (space or equipment),
employment and recruitment agreements, “joint ventures,”
Areas of Focus: Federal Anti-Kickback
Statute
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Federal Anti-kickback Statute
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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.
Areas of Focus: Stark Law
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Federal Prohibition on Physician SelfReferral (Stark Law)
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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
Areas of Focus: Stark Law
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Governs most financial relationships between physicians and
referral sources (even members of same group practice)
Space and equipment leases, any type of ownership or
compensation relationship, employment arrangements,
independent contractor arrangements
Examples of requirements:
 Written agreements
 Term of one year
 Compensation “set in advance”
 Compensation cannot vary with volume or value of referrals
 Fair market value for services/equipment
Rapid City Regional Hospital $6.5 million settlement: Provided
below-market lease of space to physician group.
Areas of Focus: Research Compliance
Human Subject Protections
 Governed by HHS and FDA rules/Good
Clinical Practices
 Proper informed consent, must follow
protocol, financial disclosures, adverse
event/other types of disclosure
requirements
 Patient safety top priority
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Areas of Focus: Research Compliance
Several High Profile Cases Involving Breakdown of
Human Subject Protections
 Jesse Gelsinger
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18 year old died in clinical trial at Univ. of Penn involving
gene replacement therapy
Investigation revealed that PI had a financial interest in
the sponsor of the trial which was not adequately
disclosed to family
Certain safety data was not adequately disclosed to family
Shutdown all gene therapy research at U Penn and at
several other institutions for a certain time period
Areas of Focus: Research Compliance
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Clinical Trial Billing
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Cannot bill third party payor for items or services
being provided “free” in trial or being paid for by
the sponsor
As Principal Investigator, must be sure to notify
institution’s finance department of billing status
Medicare now pays for “routine costs” for
patients involved in clinical trials, provided that
services associated with those costs are not
promised “free” or being paid for by the sponsor
Areas of Focus: Research Compliance
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Time and Effort Reporting Requirements
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Research involving federal funding: Must accurately
account for time spent on research project
Cannot overstate time spent on federally funded projects
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
Areas of Focus: Conflicts of Interest
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Most institutions have policies requiring disclosure of
significant financial interests in outside entities
Financial relationships with pharmaceutical companies,
medical device manufacturers, hedge funds, among others
represent potential issues
Must adequately disclose relationships so patients and
institution have full knowledge of potential conflicts
Need to manage potential conflicts to avoid impairment of
medical decision making and undue influence of outside
entities on your practice
Remain grounded: If it’s too good to be true it probably is
(also, would you want the relationship disclosed on the front
page of the local newspaper)
False Claims Act
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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
False Claims Act
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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.
Qui Tam Actions
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The FCA allows a private person (a “qui tam relator”) to
bring a civil action in the name of the United States.
In general, qui tam relators share in any money
recovered (including settlements).
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If government joins in action, relator is entitled to 15% to 25% of
proceeds depending on relator’s 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.
Exception: Qui tam relators cannot share in proceeds
when recovery is against a state institution (e.g., a state
university like ECU).
Reporting Incidents of Noncompliance
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Encouraged to use supervisors, administrators as the first
line of reporting of any known incidents of noncompliance.
BSOM Compliance Hotline
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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.
Office of Compliance at BSOM
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Serves as a resource to all faculty and staff
Contact information:
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744-5200
[email protected]