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?