This document summarizes a presentation on the False Claims Act for labor and employment and healthcare practitioners. It discusses an overview of the FCA, recent developments and trends, including the implied false certification theory and circuit split. It covers implications of individual liability under the FCA, trends in corporate integrity agreements, and practical considerations for addressing employee complaints and internal investigations.
Expungement Presentation – Gang Intervention ConferenceRecordGone
Attorneys from the Foundation, Natasha Buchanan and Mathew Higbee, provided information during two separate breakout session at the Orange County Education Departments Gang Intervention Conference on April 29, 2011. The conference was attended by approximately 500 leaders in the effort to help reduce crime and help people transition out of gangs.
This presentation discusses best practices for employers to comply with state and federal directives, develop appropriate and inclusive policies, and encourage diversity in the workplace.
Expungement Presentation – Gang Intervention ConferenceRecordGone
Attorneys from the Foundation, Natasha Buchanan and Mathew Higbee, provided information during two separate breakout session at the Orange County Education Departments Gang Intervention Conference on April 29, 2011. The conference was attended by approximately 500 leaders in the effort to help reduce crime and help people transition out of gangs.
This presentation discusses best practices for employers to comply with state and federal directives, develop appropriate and inclusive policies, and encourage diversity in the workplace.
Due to the variations in plan benefits and membership fees as well as other regulatory requirements, this presentation is to be used only in the state of New York.
What Are the Risks? Business Types Facing Increased Scrutiny: White-Collar Cr...Epstein Becker Green
Epstein Becker Green Webinar with Attorney David J. Marck - White-Collar Crash Course Webinar Series - October 17, 2017.
Discussion Points:
* Is your company subject to the Foreign Corrupt Practices Act?
* Risks in the home health care industry
* Are you a vendor to the federal government? Avoiding procurement fraud
Visit http://www.ebglaw.com/events/what-are-the-risks-business-types-facing-increased-scrutiny-white-collar-crash-course-webinar-series/
Take a coffee break every Tuesday in October at 2 p.m. ET to join us for a 15-minute webinar covering white-collar and criminal enforcement issues!
These materials have been provided for informational purposes only and are not intended and should not be construed to constitute legal advice. The content of these materials is copyrighted to Epstein Becker & Green, P.C. ATTORNEY ADVERTISING.
There are 3 ways that the LegalShield Commercial Drivers Legal Plan can help drivers and carriers:
1) Get the fine reduced.
2) Get the CSA or MVR Points reduced.
3) Get the violation dismissed.
How does that benefit the driver and carrier? The driver can maintain the privilege to drive. Earn an income. Insurance rates won't increase.
The Carrier Rating can stay high by getting a dismissal, points reduction, or fine reduction. Which, as you know, will keep your insurance premiums low.
If your Carrier rating is low, potential customers may look elsewhere when searching for a transportation company to move their freight
All of these things can affect the bottom line.
Let LegalShield help!
lburton33.wearelegalshield.com/commercial-drivers
Federal EEO Complaint Process Increased Accountability Measures NeededTanya Ward Jordan
The Coalition For Change, Inc. (C4C)'s presentation to the U.S. Equal Employment Opportunity Commission capturing eight (8) accountability measures for improving Federal EEO complaint process and thereby improving federal workforce wellness.
Forensic and Valuation Issues in HealthcarePYA, P.C.
PYA Principal Carol Carden co-presented “Forensic and Valuation Issues in Healthcare” at the AICPA Forensic & Valuation Services Conference in New Orleans, LA, November 10, 2014.
Best Practices in Physician Arrangements: Combat Contract Compliance ConcernsPYA, P.C.
OIG This presentation highlights the importance of regulatory requirements and the consequences of non-compliance for healthcare organizations that deal with physician arrangements.
Addresses regulatory considerations such as the Stark Law, Anti-Kickback Statute, and False Claims Act.
Explores additional risk areas such as OIG Fraud Alerts, Medicare Cost Report Certification, and the responsibilities of boards of directors.
Due to the variations in plan benefits and membership fees as well as other regulatory requirements, this presentation is to be used only in the state of New York.
What Are the Risks? Business Types Facing Increased Scrutiny: White-Collar Cr...Epstein Becker Green
Epstein Becker Green Webinar with Attorney David J. Marck - White-Collar Crash Course Webinar Series - October 17, 2017.
Discussion Points:
* Is your company subject to the Foreign Corrupt Practices Act?
* Risks in the home health care industry
* Are you a vendor to the federal government? Avoiding procurement fraud
Visit http://www.ebglaw.com/events/what-are-the-risks-business-types-facing-increased-scrutiny-white-collar-crash-course-webinar-series/
Take a coffee break every Tuesday in October at 2 p.m. ET to join us for a 15-minute webinar covering white-collar and criminal enforcement issues!
These materials have been provided for informational purposes only and are not intended and should not be construed to constitute legal advice. The content of these materials is copyrighted to Epstein Becker & Green, P.C. ATTORNEY ADVERTISING.
There are 3 ways that the LegalShield Commercial Drivers Legal Plan can help drivers and carriers:
1) Get the fine reduced.
2) Get the CSA or MVR Points reduced.
3) Get the violation dismissed.
How does that benefit the driver and carrier? The driver can maintain the privilege to drive. Earn an income. Insurance rates won't increase.
The Carrier Rating can stay high by getting a dismissal, points reduction, or fine reduction. Which, as you know, will keep your insurance premiums low.
If your Carrier rating is low, potential customers may look elsewhere when searching for a transportation company to move their freight
All of these things can affect the bottom line.
Let LegalShield help!
lburton33.wearelegalshield.com/commercial-drivers
Federal EEO Complaint Process Increased Accountability Measures NeededTanya Ward Jordan
The Coalition For Change, Inc. (C4C)'s presentation to the U.S. Equal Employment Opportunity Commission capturing eight (8) accountability measures for improving Federal EEO complaint process and thereby improving federal workforce wellness.
Forensic and Valuation Issues in HealthcarePYA, P.C.
PYA Principal Carol Carden co-presented “Forensic and Valuation Issues in Healthcare” at the AICPA Forensic & Valuation Services Conference in New Orleans, LA, November 10, 2014.
Best Practices in Physician Arrangements: Combat Contract Compliance ConcernsPYA, P.C.
OIG This presentation highlights the importance of regulatory requirements and the consequences of non-compliance for healthcare organizations that deal with physician arrangements.
Addresses regulatory considerations such as the Stark Law, Anti-Kickback Statute, and False Claims Act.
Explores additional risk areas such as OIG Fraud Alerts, Medicare Cost Report Certification, and the responsibilities of boards of directors.
To hear the recorded version of this webinar, visit http://bit.ly/1JqXkox
Our panel discusses developments in government enforcement of health care anti-fraud laws. This will include recent court decisions, settlements and OIG/DOJ pronouncements and public statements. The focus will be on development in 2015 year to date. The panel will also discuss significant "cases to watch" that are in active litigation and could result in decisions that impact the industry.
On our agenda:
Overview of recent government enforcement efforts
Highlight of significant False Claims Act decisions in 2015
Discussion of pending cases and their implications for the industry
Presenters:
Jeffrey Fitzgerald, Shareholder, Polsinelli
Brian Bewley, Shareholder, Polsinelli
PeopleMatter partner, SterlingBackcheck, walks through how new Fair Credit Reporting Act (FCRA) regulations are impacting the background screening process ... for better or for worse.
This webinar will provide a quick update on health care data privacy and security matters, including recent breaches, government enforcement actions and the rise in state law claims. We will also address the need for cyber liability insurance and provide key points in selecting the right policy or evaluating your existing policy.
On the agenda:
Basis of a Breach
Recent Settlements/Enforcement Areas
State Actions on the Rise
Need for Cyber Liability Insurance
Auditing Healthcare Focus Arrangements for Regulatory CompliancePYA, P.C.
PYA Principal Tynan Kugler and Consulting Manager Susan Thomas presented “Auditing Healthcare Focus Arrangements for Regulatory Compliance: Physicians, Management Services, Post-Discharge Care, Ambulance Services, and Specialty Care.” Their presentation:
- Describes what constitutes a focus arrangement for healthcare organizations.
- Explains the implications of Stark Law and Anti-Kickback violations, along with Corporate Integrity Agreement focus arrangement requirements.
- Discusses essential focus arrangement procedures to facilitate regulatory compliance.
- Provides an example design of an audit plan approach for focus arrangements.
Millions Involved in False Claims Act Cases: Medical Fraud and Recent Court D...Conference Panel
Join our advanced webinar to gain a comprehensive understanding of federal false claims act laws, and learn how to avoid liability and maintain defensible record-keeping in the context of medical waste, fraud, and abuse cases involving millions of dollars.
This webinar provides an in-depth overview of the two types of prosecutions for alleged false claims, and explores the real-world outcomes of federal cases, including landmark rulings from the United States Supreme Court that have changed the landscape of false claims act cases.
Through an analysis of federal court cases, attendees will gain insights into the potential risks and consequences of non-compliance, and learn practical tips and techniques to mitigate risk and ensure compliance with federal false claims act laws. Don't miss this opportunity to stay ahead of the curve in this complex and constantly evolving area of the law.
Register, https://conferencepanel.com/conference/false-claims-act-cases-involving-millions-in-medical-fraud-what-you-need-to-know-about-recent-court-decisions
Long Term Care Litigation - Conference Materials Rachel Hamilton
Gain the competitive advantage in increasingly high-stakes long term care defense at ACI’s 3rd Annual Forum on Preventing and Defending Long Term Care Litigation, the only conference that brings together a supreme in-house presence on the faculty, the top defense firms, and experienced jurists from around the country. Designed for both networking and masters-level strategy sharing, this is the leading forum in which to learn winning strategies to comply with the dense thicket of laws and regulations facing the LTC industry, avoid costly litigation altogether and to mount a complete and formidable defense if forced to do so.
Tax Cuts & Job Act Implications for Small Business Investments Companies Polsinelli PC
On December 22, 2017, the President signed into law a federal tax reform bill commonly known as the Tax Cuts & Jobs Act (the “Tax Act”). The Tax Act resulted in significant changes to the U.S. tax system on a number of fronts. This webinar will provide an overview the provisions of the Tax Act relevant to SBIC’s. We will also address the impact of the Tax Act upon the choice of entity decisions and a number of ancillary matters.
Preventing Compliance Quagmires in Senior Living Communities: Part 1 - Can So...Polsinelli PC
During this webinar we will explore the regulatory, operational and employment related issues that arise when long term care staff use social media at work in the long term care setting.
Health Care "Prime" - The Future of the Ownership, Organization, Payment, and...Polsinelli PC
The potential for disruption and disaggregation of traditional and incumbent players is occurring across the health care ecosystem and care continuum, and may accelerate through the intended and unintended consequences of this innovative new venture. Is this partnership a seminal event in defining the future of health care? Author William Gibson said, “The future is already here – it’s just not very evenly distributed.” This statement applies as the future of health care fast approaches, but with variability across stakeholders, their businesses, and the communities in which they provide care as part of one of America’s largest industries.
A diverse panelist group will bring a broad range of current perspectives and insights related to this partnership. From the base of the panelists’ unique perspectives, they will discuss their views on the likely near-, mid- and long-term implications of this announced venture on the ownership, organization, payment, and delivery of health care products, supplies and services in America.
The Trump Labor Board Goes Back to the FuturePolsinelli PC
The last weeks of 2017 brought significant changes to the National Labor Relations Board and federal labor law. Polsinelli’s Traditional Labor Practice Group will cover all of these changes, including the short-lived Republican majority, the new Board members and General Counsel, a recap of the major decisions reversing several of President Obama’s pro-employee initiatives over the last eight years, and discuss what is in store for employers in 2018.
Lessons learned from litigating real estate development projectsPolsinelli PC
Real estate development projects are filled with uncertainty. Zoning and permitting denials, disputes with neighboring property owners and citizen groups, and ambiguity in development contracts can cause significant setbacks to even the most well planned developments. This webinar will explore the many pitfalls of the development process and how to navigate them. Four Polsinelli attorneys offer their guidance and insights gained from litigating these very types of issues.
Datascram is being called a massive “Datascam.” Engineers cut corners and, as it turns out, data is not deleted forever. Instead, once deleted, it resides on a Nigerian server where it is sold to the highest bidder. As the company prepares to shut its doors, new questions emerge about Damian Diamond’s role in the fiasco and whether he could be held personally responsible for the company’s potentially criminal activities.
There is a glut of competitive product on the market, and sales and the company stock price are down. Damien Diamond has ordered immediate cost cutting, with significant implications both for the company's bottom line and the lives of the employees currently on the payroll. Failure to proceed in accordance with the law could make Datascram's problems even worse.
Car Accident Injury Do I Have a Case....Knowyourright
Every year, thousands of Minnesotans are injured in car accidents. These injuries can be severe – even life-changing. Under Minnesota law, you can pursue compensation through a personal injury lawsuit.
A "File Trademark" is a legal term referring to the registration of a unique symbol, logo, or name used to identify and distinguish products or services. This process provides legal protection, granting exclusive rights to the trademark owner, and helps prevent unauthorized use by competitors.
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NATURE, ORIGIN AND DEVELOPMENT OF INTERNATIONAL LAW.pptxanvithaav
These slides helps the student of international law to understand what is the nature of international law? and how international law was originated and developed?.
The slides was well structured along with the highlighted points for better understanding .
In 2020, the Ministry of Home Affairs established a committee led by Prof. (Dr.) Ranbir Singh, former Vice Chancellor of National Law University (NLU), Delhi. This committee was tasked with reviewing the three codes of criminal law. The primary objective of the committee was to propose comprehensive reforms to the country’s criminal laws in a manner that is both principled and effective.
The committee’s focus was on ensuring the safety and security of individuals, communities, and the nation as a whole. Throughout its deliberations, the committee aimed to uphold constitutional values such as justice, dignity, and the intrinsic value of each individual. Their goal was to recommend amendments to the criminal laws that align with these values and priorities.
Subsequently, in February, the committee successfully submitted its recommendations regarding amendments to the criminal law. These recommendations are intended to serve as a foundation for enhancing the current legal framework, promoting safety and security, and upholding the constitutional principles of justice, dignity, and the inherent worth of every individual.
ALL EYES ON RAFAH BUT WHY Explain more.pdf46adnanshahzad
All eyes on Rafah: But why?. The Rafah border crossing, a crucial point between Egypt and the Gaza Strip, often finds itself at the center of global attention. As we explore the significance of Rafah, we’ll uncover why all eyes are on Rafah and the complexities surrounding this pivotal region.
INTRODUCTION
What makes Rafah so significant that it captures global attention? The phrase ‘All eyes are on Rafah’ resonates not just with those in the region but with people worldwide who recognize its strategic, humanitarian, and political importance. In this guide, we will delve into the factors that make Rafah a focal point for international interest, examining its historical context, humanitarian challenges, and political dimensions.
3. Co-presented by:
Fraud & Abuse Laws
False Claims Act
– Civil liability for submitting false claims for payment to the
government
– Also, liability for failure to refund identified overpayment
within 60 days
– Noncompliance with regulations can make claims “false”
so AKS and Stark can be bootstrapped
– Penalty: up to 3x damages plus $11,000 per claim
– Offers a bounty for whistleblowers
• Up to 25% of recovery plus fees
• 90%+ of cases are whistleblower driven
4. Co-presented by:
Implied False Certification Theory
Traditional FCA liability arises in cases involving claims that
are factually false
– EX: a health care provider bills for goods or services that
were never performed or submits a bill containing altered
CPT or ICD-9 codes
False certification liability involves claims that are legally false
– EX: the person or entity submitting the claim for payment
has failed to comply with applicable statutes, regulations,
or contractual provisions underlying the claim for payment
5. Co-presented by:
Express v. Implied Certifications
The “legally false” certification can be express or implied
– An express false certification occurs when the
person/entity submitting the claim expressly certifies
compliance with ancillary legal requirements, either at the
time the claim is submitted or at some other point in time
– “Implied false certification” cases rest on the theory that a
person or entity receiving federal funds implicitly certifies,
every time it makes a claim for payment, that it has
complied with applicable legal requirements, even though
no express certification of compliance has been made
6. Co-presented by:
Implied False Certification Circuit Split
Second, Third, Sixth, Ninth, Tenth, and Eleventh Circuits
recognize implied certification liability only where the
statute, regulation, or contractual provision that has allegedly
been violated expressly states that compliance with it is a
precondition of payment
First, Fourth, and D.C. Circuits hold that liability attaches for
any violation of statutory, regulatory, or contractual
requirements, so long as compliance with those requirements
was material to the government’s decision to pay
Materiality often determined in hindsight
7. Co-presented by:
Implications of Circuit Split
Many FCA cases rely on the implied certification
theory of falsity
– Relators who lack firsthand knowledge of the actual claims
can often survive motions to dismiss
– Relators can argue that all claims submitted by a
defendant while in violation of a regulation, statute, or
contract were false
Encourages and rewards forum shopping
Different outcomes under factually identical
circumstances based on where the case is filed
8. Co-presented by:
What’s at Stake
Treble damages and civil penalties of up to $11,000 per claim
Exclusion from participation in federal health care programs
Payment suspension
Potential criminal liability
Follow-on suits under state false claims acts
Reputational harm (DOJ announcements; SEC and other
mandatory public disclosures)
Legal costs
Increased scrutiny and monitoring (e.g., Corporate Integrity
Agreements)
9. Co-presented by:
Universal Health Services, Inc. v.
United States ex rel. Escobar
–Supreme Court to resolve circuit split
–United States ex rel. Escobar v. Universal
Health Services, Inc.,780 F.3d 504, 512-13
(1st Cir. 2015)
• A claim is false or fraudulent whenever a defendant
fails to comply with a material—rather than express—
regulatory precondition of payment
10. Co-presented by:
Issues on Appeal
– Whether the “implied certification” theory of legal falsity under
the FCA is viable
– Whether, if the “implied certification” theory is viable:
• Failure to comply with a statute, regulation, or contractual
provision that does not state that it is a condition of
payment can result in liability for a legally false claim (1st
, 4th
,
and D.C. Circuits);
• Liability for a legally false claim requires that the statute,
regulation, or contractual provision expressly state that it is
a condition of payment (2nd
and 6th
Circuits)
– 27 Amici Briefs have been filed
11. Co-presented by:
Oral Argument
April 19, 2016
UHS:
– Supreme Court should reject the implied certification theory in its
entirety
• FCA is a punitive statute that imposes treble damages and civil
penalties - should not be used to police compliance with every
regulatory, statutory, or contractual requirement related to a
claim for payment
• FCA’s treble damages and other penalties would eclipse the fines
that the regulatory agencies deemed appropriate for the mental
health clinic’s conduct
– Alternatively, should the Supreme Court recognize the theory, it
should limit it to violations of requirements that are express
preconditions to payment
12. Co-presented by:
Oral Argument
April 19, 2016
Relators/Government
– Limiting FCA liability to violations of legal
requirements that are express conditions to
payment would create a loophole through which
providers could escape liability for knowing
violations of material requirements
13. Co-presented by:
Oral Argument
April 19, 2016
Court appears likely to recognize implied certification liability
in some form
Questions generally focused on where the line should be
drawn—i.e., when does a statutory, regulatory, or contractual
violation give rise to FCA liability?
– Too narrow – FCA will not be able to reach the kinds of
fraud it was intended to combat
– Too broad – application will result in mammoth damages
and civil penalties for every statutory, regulatory,
contractual violation, no matter how de minimis
14. Co-presented by:
Practical Considerations
If the Court is deadlocked 4-4, the First
Circuit’s decision in Escobar will be upheld and
the Supreme Court’s decision will not be
precedent on the other circuits, which would
leave the current circuit split unresolved
The Court’s decision is expected by June 2016
15. Co-presented by:
Practical Considerations
If served with an FCA complaint asserting implied certification claims, a defendant
should be thinking about:
– A robust motion to dismiss strategy
• Regulation, statute or contract was not actually violated
• Regulation is not a condition of payment
– Regulatory (or statutory, or contractual) scheme may designate
other regulations as conditions of payment, but not the one at issue
– Regulatory infraction may be so minor that it could not conceivably
be a condition of payment
– Government payor may have its own remedies for redressing
violations, demonstrating payor did not condition payment on
compliance
– Absence of a condition of payment requires dismissal for failure to
plead both falsity and materiality
• Rule 9(b) remains a critical defense in implied certification cases - implied
certification cases particularly ripe for Rule 9(b) dismissal
16. Co-presented by:
Practical Considerations
Make aggressive use of discovery to negate falsity,
materiality, and knowledge and set up summary judgment in
an implied certification case:
– The government payor did not condition payment on
compliance with the regulation at issue
– The regulation does not mean what the relator says it
means or that the regulation was ambiguous
– The government knew about the defendant’s practices
– In healthcare cases in particular, that reasonable medical
minds may differ on a service or treatment
18. Co-presented by:
DOJ Yates Memo:
The Call For Increased Individual Liability
Increased Focus on Individuals
“Cooperation Credit”
“Focus on individuals”
“Routine communication” among
criminal/civil attorneys
No corporate resolution absent “clear plan”
on individuals
19. Co-presented by:
DOJ Yates Memo:
Limited Individual Releases
Past practice: global individual release
Present policy: no individual release absent
“extraordinary” circumstances
Impacts: continued risk of criminal, civil,
administrative penalties
20. Co-presented by:
DOJ Yates Memo:
Civil Enforcement and Ability to Pay
Not dispositive
Must consider: seriousness of individual’s
misconduct, likelihood of judgment, existence
of important “federal interest”
21. Co-presented by:
DOJ Yates Memo:
Rhetoric or Reality
Potential implications
– DOJ fear of bad precedent based on individual
enforcement risks
– Chilling effect on individual interviews in
corporate internal investigations
– Constrained corporate disclosures
22. Co-presented by:
Corporate Integrity Agreements
(CIA)
Condition for continued funding from federal
and state programs
Requires implementation of effective
compliance program
OIG Monitor
Annual reporting and IRO reviews
Typically five-year proposition
Additional costs above settlement amount
23. Co-presented by:
Columbus Regional
Healthcare Systems, Inc.
CRHS – Columbus, GA
– Settlement Date: September 3, 2015
– Allegations:
• Improper physician arrangement
• Over-billing of office visits and other services
– Whistleblower – Administrator of cancer center
– Settlement
• Columbus Regional Healthcare Systems - $25,000,000+
• Medical Director - $425,000
24. Co-presented by:
The Medical Center of
Central Georgia, Inc.
MCCG – Macon, GA
– Settlement Date: April 23, 2015
– Allegations:
• Improper billing of claims
• Unnecessary inpatient admissions
– Health Care Fraud Prevention and Enforcement
Action Team (HEAT)
– Settlement: $20,000,000
25. Co-presented by:
Memorial Health, Inc.
Memorial Health – Savannah, GA
– Settlement Date: December 22, 2015
– Allegation:
• No business rationale for recruitment of PCPs
• Overpayment of physicians for referrals
– Whistleblower – former CEO
– Settlement: $10,000,000
26. Co-presented by:
Pediatric of Services of America, Inc.
PSA – Atlanta, GA
– Settlement Date: July 27, 2015
– Allegations:
• Improper billing of unsupported and overstated claims
– Two Whistleblowers – billing specialist and
director of clinical nursing
– Settlement: $6,900,000
27. Co-presented by:
Irwin County Hospital
ICH – Ocilla, GA
– Settlement Date: April 21, 2015
– Allegation:
• Improper physician arrangements
• Physician compensation in excess of FMV
• Billing for services lacking appropriate supervision
– Whistleblowers – two x-ray technicians
– Settlement: $520,000
28. Co-presented by:
Trends in Corporate
Integrity Agreements
Independent directors
Board oversight of Compliance Program
Management Certifications
Executive compensation clawbacks
Training Plan
29. Co-presented by:
Trends in Corporate
Integrity Agreements (cont.)
Annual Risk Assessment
Compliance Expert
Overpayments review
Increased fines related to false Implementation
Reports and Annual Reports
30. Co-presented by:
Updated DOJ Statistics
Total recoveries down by almost $2.2B
In FY15 85% of new matters based on qui tam actions, and recoveries from qui tam
actions exceeded DOJ initiated enforcement by ~$2.2B
Huge jump in recoveries from non-intervened cases, largest $ in FCA history
31. Co-presented by:
Co-presented by:
Panel 2
L&E Issues: Addressing and
Investigating Employee Complaints
Steve Fox, Tim Jefferson, Nancy Rafuse, and Justin
Snell
32. Co-presented by:
Who is a Whistleblower?
Any employee, contractor, or agent …
– Any employee, contractor or agent shall be
entitled to all relief necessary to make that
employee, contractor or agent whole if that
employee, contractor or agent is discharged,
demoted, suspended, threatened, harassed, or in
any other manner discriminated against in the
terms and conditions of employments because of
lawful acts done by the employee, contractor or
agent or associated with others in furtherance of
other efforts to stop 1 or more violations of this
subchapter. 31 USC Section 3730(h)
33. Co-presented by:
Establishing Claim
To establish FCA retaliation claim, plaintiff must
establish
– He engaged in protected activity
– Employer knew of these acts and
– Employer took adverse action against him because of those acts
FCA applies same general burden shifting analysis
and framework applied in discrimination cases:
– Once the plaintiff establishes a prima facie case – protected
activity, adverse action and causal connection –employer
produces evidence of a legitimate, non-discriminatory reason for
the adverse action
– Plaintiff must prove that the reason is not the true reason, but a
pretext for retaliation
34. Co-presented by:
Protected Activity
“The relevant inquiry when determining
whether an employee’s actions are protected is
whether (1) the employee in good faith believes
and (2) a reasonable employee in the same or
similar circumstances might believe that the
employer is committing fraud against the
government.”
35. Co-presented by:
Protected Activity
“Confused pharmacist” (Clinkscales v.
Walgreens)
– “Paul,
• Jackie told me tonight that you told her for me to do a
bin reconciliation to see if we could clear up the register
problem I believed occurred Tuesday 06/15 where rx’s
were sold but still say ready in work Q on intercom+.
The report is done over 200 rx’s were in (ready not in
bin status) – highlighted in blue or rx’s that were
generated after 06/15? – (I hope this makes verification
of register transactions easier). The report is in mgr.
box in office. Wes”
36. Co-presented by:
Protected Activity
“Confused pharmacist” (Clinkscales v.
Walgreens)
– “Paul,
• I just saw the note I jotted down of what Jackie was
telling me that you were telling her for me to do. I
wrote down that any item I could not find on bin recon
– you wanted me to price modify to $0. Doe this mean
I’ll need to print the 200 leaflets for the rx’s that
showed up (ready not in the bins) then ring up at
register. Also, if there are rx’s on bin recon that were
not involved in the register problem how are they
accounted for? I’m not sure how to correctly do this.
Wes”
37. Co-presented by:
Protected Activity
“Confused pharmacist” (Clinkscales v.
Walgreens)
– Court held that pharmacist had not engaged in
protected activity
• “[His] conduct amounts to merely asking how he could
correctly perform a job function, not reporting or
attempting to stop misconduct under the FCA. [He] did
not state that he thought the bin reconciliation was illegal
or unlawful or express any concerns about it creating the
potential for fraudulent billing. He also did not refuse to
complete the bin reconciliation, he merely asked how to
do it correctly. Such activity is not protected by the FCA
whistleblower provision.”
38. Co-presented by:
Decision to Initiate
Internal Investigation
Internal investigation warranted where allegations involve
widespread misconduct, misconduct by sr. management, or
violations of state/federal civil or criminal statutes (FCA, Stark, AKS)
Prompt internal investigation especially important where
government scrutiny possible
Ignoring complaints could lead to disgruntled employee becoming
FCA whistleblower
Internal investigation provides company with critical information
early on
The faster facts are learned, the greater the chance company can
minimize harmful consequences (reputational damage, loss of
business, damages and penalties)
39. Co-presented by:
Releases
General release language releases party from all claims, causes of
action and damages of whatsoever nature
General exceptions
– “… except those claims that cannot lawfully be released” or “ … except those
claims that cannot be released by law or statute.”
Specific exceptions
– “Laundry-list” of carve outs: workers compensation claims, FLSA claims,
enforcement of the release agreement, certain state laws
Representations
– Employee represents that he is not aware of any information and does not
have any documents which evidence any fraud by employer against the
government and by signing this agreement is affirmatively representing that
he is not aware of and has not been made aware of any such fraud
40. Co-presented by:
Confidentiality
Restriction on confidentiality agreements that limit
or restrict employees from reporting fraud and
abuse to government
Requires government contractor to represent that it does not
require employees to sign confidentiality agreements that
prohibit or otherwise restrict lawful reporting of waste, fraud
or abuse
Return of confidential documents
– Courts willing to recognize a public policy exception for confidential
documents that form the basis of a qui tam action
41. Co-presented by:
Federal Trade Secrets Bill
(b) IMMUNITY FROM LIABILITY FOR CONFIDENTIAL
DISCLOSURE OF A TRADE SECRET TO THE GOVERNMENT OR
IN A COURT FILING.—
– (1) IMMUNITY.—An individual shall not be held criminally or civilly
liable under any Federal or State trade secret law for the disclosure of
a trade secret that—
• (A) is made
– (i) in confidence to a Federal, State, or local government official,
either directly or indirectly, or to an attorney; and
– (ii) solely for the purpose of reporting or investigating a suspected
violation of law; or
• (B) is made in a complaint or other document filed in a lawsuit or other
proceeding, if such filing is made under seal.
42. Co-presented by:
Federal Trade Secrets Bill
(3) NOTICE.—
– (A) IN GENERAL.—An employer shall provide notice of the immunity set forth in this
subsection in any contract or agreement with an employee that governs the use of a trade
secret or other confidential information.
– (B) POLICY DOCUMENT.—An employer shall be considered to be in compliance with the
notice requirement in subparagraph (A) if the employer provides a cross-reference to a
policy document provided to the employee that sets forth the employer's reporting policy
for a suspected violation of law.
– (C) NON-COMPLIANCE.—If an employer does not comply with the notice requirement in
subparagraph (A), the employer may not be awarded exemplary damages or attorney fees
under subparagraph (C) or (D) of section 1836(b)(3) in an action against an employee to
whom notice was not provided.
– (D) APPLICABILITY.—This paragraph shall apply to contracts and agreements that are entered
into or updated after the date of enactment of this subsection.
– (4) EMPLOYEE DEFINED.—For purposes of this subsection, the term ‘employee’ includes any
individual performing work as a contractor or consultant for an employer.
– (5) RULE OF CONSTRUCTION.—Except as expressly provided for under this subsection,
nothing in this subsection shall be construed to authorize, or limit liability for, an act that is
otherwise prohibited by law, such as the unlawful access of material by unauthorized means.
43. Co-presented by:
Potential Counterclaims v.
Whistleblower
Breach of contract/fraud
Theft of documents/trade secrets
Computer fraud and abuse act
Libel/slander/defamation
44. Co-presented by:
Investigations
Be Prepared
– Risk Assessments
– Investigative Protocols
Professional skepticism & minimization
– Whistleblower bias
– Overstating controls
Scoping and planning
– Too broad or too narrow scope
– Starting too soon
– Planning considerations
45. Co-presented by:
Dealing with Whistleblower
During Investigation
Keep whistleblower informed of status of investigation
Inform whistleblower of outcome of investigation (without
disclosing privileged information)
Keep whistleblower’s identity confidential
Protect whistleblower from obvious retaliatory conduct
(discharge, demotion, suspension, threats/discrimination)
– Protect whistleblower from actions that could be perceived as
retaliatory (denying a leave request, scheduling the employee for
fewer hours, excluding the employee from certain meetings or
projects, or applying a higher level of scrutiny to the employee or
his/her work)
46. Co-presented by:
Reporting Mechanisms
Design
– History & Evolution
– More than a hotline
– Anonymity
– Anti-Retaliation
– Metrics
Evaluation
– Periodic audits
– Document changes
47. Co-presented by:
Co-presented by:
Panel 3
Maintaining a Culture of Compliance:
Prevention, Deterrence & Monitoring
Ross Burris, Billy Carr, Matt Grosvenor, and Jim
Swartz
48. Co-presented by:
An Ounce of Prevention…
Healthcare in a fast moving reactionary environment
Attorney’s and administrator’s fiduciary responsibility is to
the board and institution
Deals often occur “behind closed doors”—but the earlier the
attorney becomes involved the better
The best prevention is through a corporate compliance policy
and documentation
Advise client to have an annual Corporate Compliance audit
by an outside source to review all contracts at risk in the past
year and review current deals under discussion
Know your government representatives who participate in
corporate investigations
49. Co-presented by:
Conducting Effective Internal
Investigations
The (Not Always) Unique World of Health
Care Investigations
Choosing Wisely – How and Who Should
Conduct the Investigation
Following the Right Playbook - Protecting
Your Client’s Interests and Maintaining
Privilege
Where Do We Go From Here - Next Steps
After Concluding the Investigation
50. Co-presented by:
They’re ALL Watching You …
RACs/
ZPICs
State
Legislatures
State AGs
Congress Medicaid
HHS
FTC
FDA
DOJ/DOL/
EEOCPlaintiff
Lawyers
Whistle-
blowers
Commercial
Payors
Personal
Injury
Litigants
Competitors
OIG
PRESS
Medicare/CMS
YOU
The (Not Always) Unique World of Health
Care Investigations
51. Co-presented by:
The (Not Always) Unique World of
Health Care Investigations
It Usually Begins With…
Search Warrant, Subpoena or Civil Investigative Demand (CID)
from a government body
Response to problems uncovered through compliance program
audit, hotline call, or HR issue
Response to allegations of wrongdoing reported through a
whistleblower
State licensing boards or accreditation organizations
Actual or threatened civil litigation (e.g., class actions)
Response to allegations raised by customers, vendors or
competitors
52. Co-presented by:
The (Not Always) Unique World of
Health Care Investigations
Spotting the Hidden Complaint
Not all complaints triggering investigation are
easy to identify.
Exit interview comments
“Rumors” or overheard comments about
inappropriate/illegal conduct
Informal comments about relationships
between or treatment of certain
employees/vendors
53. Co-presented by:
The (Not Always) Unique World of
Health Care Investigations
The Benefits of an Investigation
Demonstrates a good-faith response by the Company
Will allow the Company to take remedial action or
make a self-disclosure
Remedial actions or self-reporting may minimize the
risk or potential penalties
Negative consequences of not conducting an
investigation could be increased penalties by
government agencies and/or useful evidence may be
lost or destroyed
54. Co-presented by:
The (Not Always) Unique World of
Health Care Investigations
Different Circumstances, Similar Goals…
Quickly obtain accurate information to facilitate the necessary
legal advice, compliance assessment, and informed decision
making
Maintain the confidentiality of the investigation and protect
the information acquired from an undesired or non-strategic
disclosure
Prepare for and implement remedial action and limit risk
Cooperate with the investigative body while protecting
organization’s rights
55. Co-presented by:
Choosing Wisely – How and Who Should
Conduct an Internal Investigation
Develop an Investigation Plan:
– Define the purpose and scope
– Issue a litigation hold notice to ensure no
essential information is destroyed
– Identify witnesses to be interviewed
– Determine potential sources of information
– Put together the investigation team
56. Co-presented by:
Choosing Wisely – How and Who Should
Conduct an Internal Investigation
Business and Operational Considerations:
– Some problems are best handled by in-house lawyers, HR,
or compliance personnel
– Can’t always pick up the phone and call outside counsel
• Cost
• Managing personalities
• Institutional knowledge
– Impact on business operations and availability of
resources
57. Co-presented by:
Choosing Wisely – How and Who Should
Conduct an Internal Investigation
Legal Considerations:
– Protecting privilege
– Litigation hold notice
– Need for objectivity and independence
– Relationships with or knowledge of the regulators
– Subject matter experience
– Is the approach going to be defensible?
– Investigator may be a witness
58. Co-presented by:
Choosing Wisely – How and Who Should
Conduct an Internal Investigation
Red Flags, When To Consider Calling Outside Counsel
– Any time there is potential for criminal culpability
– Allegations against senior management or board
– Systemic or wide ranging issues spanning an extended
period of time
– Financial risk to the organization is high (bet the company)
– Anticipation of collateral litigation
– In-house interviews may be considered as “business” in
nature, and therefore not protected
Circumstances change quickly, who conducts an
investigation not set in stone
59. Co-presented by:
Following the Right Playbook -
Protecting Your Client’s Interests
Preparation of a work plan, making decisions
about scope
Getting the word out, taking a balanced
approach to explain to employees purpose of
investigation
Consider working with PR groups if allegations
are publicly known
60. Co-presented by:
Following the Right Playbook -
Protecting Your Client’s Interests
Collecting and Retaining Documents
– Identify potential sources of relevant documents
– Implement a “Do Not Destroy” notice or similar litigation hold notice
– Notice should be sent to anyone who may have relevant documents
– IT and other departments should be notified to suspend document
destruction policies
Potentially Responsive Documents May Include
– Emails
– Financial records
– Complaints
– Policies and procedures
61. Co-presented by:
Following the Right Playbook -
Protecting Your Client’s Interests
Interviewing current and former employees
– In-person is always best
– Never conduct interviews alone
– Interviews should not be recorded or transcribed (second
person can take notes)
Protect the attorney-client privilege and attorney
work product materials
– Discuss key documents with interviewees
– Documents should be marked as privileged or attorney
work product
62. Co-presented by:
Following the Right Playbook -
Protecting Your Client’s Interests
Give Upjohn warnings in some circumstances
– Upjohn v. U.S., 449 U.S. 383 (1981), held that
communications between the Company’s counsel
and employees is privileged (but the privilege
belongs to the Company)
– Employees should be aware that you represent
the Company, not them as individuals
63. Co-presented by:
Following the Right Playbook -
Protecting Your Client’s Interests
Considering Joint Defense Agreements
– Continental Oil Co. v. U.S., 330 F.2d 347 (9th Cir.
1964) recognized a “joint defense privilege”
where some communications can be disclosed to
a third party without waiving privilege
– Useful when employees engage their own counsel
– Check local law to confirm scope and applicability
of this privilege
64. Co-presented by:
Where Do We Go From Here - Next Steps
After Concluding the Investigation
Assessing potential criminal, regulatory or civil liability
Consider whether report will be oral or written
Reporting requirements (need for self-disclosure):
– Government
– Board of directors
– Outside auditors
Notification requirements to insurance carriers, state licensing boards,
NPDB
Need for employee disciplinary actions
Modification of policies and procedures or corporate practices
Extent and content of any communication with employees or the public
65. Co-presented by:
Where Do We Go From Here - Next Steps
After Concluding the Investigation
Practical Guidance for Health Care Governing Boards on
Compliance Oversight
– Office of the Inspector General, Department of Health and Human
Services
– Association of Healthcare Internal Auditors
– American Health Lawyers Association
– Health Care Compliance Association
Board of Director Oversight
– Compliance, Legal, Internal Audit: Roles and Relationships
– Issue reporting within an organization
– Risk identification approach
– Enterprise-wide accountability for compliance goals
66. Co-presented by:
Discussion
Should I keep all deal deliberations under
attorney client privilege?
What can human resources professionals do
to assist with investigations?
What are the OIG’s expectations of
Companies with respect to monitoring
compliance?
What are some ways that Board members
should be engaged with compliance?