healthcare fraud and abuse: rigorous compliance to avoid
TRANSCRIPT
Healthcare Fraud and Abuse: Rigorous Compliance to Avoid Penalties Leveraging Lessons from Recent Settlements, Court Rulings and Advisory Opinions
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THURSDAY, JANUARY 23, 2014
Presenting a live 90-minute webinar with interactive Q&A
Laura F. Laemmle-Weidenfeld, Partner, Patton Boggs, Washington, D.C.
Paul Weidenfeld, Partner, Liles Parker, Washington, D.C.
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Laura Laemmle-Weidenfeld
Partner, Patton Boggs LLP
Paul S. Weidenfeld
Partner, Liles Parker PLLC
Health Care Fraud Enforcement Trends • Noteworthy Settlements
• Key court decisions
• HHS-OIG Advisory Opinions
• CMS program integrity efforts
Strategies for Implementing and Maintaining Compliance Programs • Designing a program
• Implementing a program
• Responding to violations
Self-Disclosure Options
2
3
Collected about $3.2 billion in civil and criminal
health care fraud actions in FY 2013
4
Health Care Fraud Prevention and Enforcement Team (HEAT)
• Established May 20, 2009
• Joint DOJ-HHS Collaboration Led by Deputy Attorney General and HHS Deputy Secretary
Expanded data sharing and improved information sharing procedures to track
patterns of fraud and abuse and increase efficiency in investigating and
prosecuting complex health care fraud cases.
Cross-government health care fraud data intelligence sharing workgroup to share
fraud trends, new initiatives, ideas, and success stories to improve awareness across
the government of issues relating to health care fraud.
Provide training to federal prosecutors
Medicare Strike Force effort
5
Medicare Strike Force
• Began in Miami in 2007
• Now Also in
— LA
— Detroit
— Houston
— Brooklyn
— Baton Rouge
— Tampa
— Dallas
— Chicago
Seeks to Prevent and/or Aggressively Prosecute Health Care Fraud
6
May 2013 takedown
• Nationwide takedown in eight cities
• Resulted in charges against 89 individuals, including doctors, nurses and other licensed medical professionals
• Alleged Medicare fraud schemes involving approximately $223 million in false billings
• 6th takedown
By December 2013, the Strike Force had charged more than 1700 defendants who collectively billed Medicare more than $5.5 billion
7
Key areas of prosecution:
• Mental health, especially Community Mental Health Centers
(kickbacks, medically unnecessary services, medically ineligible
patients, falsification of documentation)
• Home health (kickbacks, fraudulent certifications, other
falsification of eligibility)
• DME (equipment medically unnecessary and/or not provided)
• Physical therapy (kickbacks, services not provided)
• Hospice and palliative care (medically ineligible patients)
8
Johnson & Johnson (J&J) and subsidiaries announced $2.2
billion global resolution
• Allegations of off-label promotion (promoting drugs for uses
not approved as safe and effective by FDA), and payment of
kickbacks to physicians and to the nation’s largest long-term
care pharmacy provider
• $485 million in criminal fines and forfeiture
• $1.72 billion in False Claims Act civil settlements with the
federal government and states totaling $1.72 billion
9
Ranbaxy USA, May 2013
• Guilty plea to 3 felony FDCA counts and 4 felony counts of
knowingly making material false statements to the FDA
• Criminal fine and forfeiture of $150 million
• Civil settlement under FCA for $400 million ($232 federal,
$118 state)
10
• FCPA (e.g., Orthofix International, N.V., 7/2012 DPA and
$2.2 million fine for alleged improper payments to Mexican
officials to influence purchases of Orthofix’s medical devices
by Mexican government-operated hospitals; arose out of self-
disclosure)
• Organized crime (e.g., individual sentenced 2/8/13 in SDNY
for involvement with Mirzoyan-Terdjanian Organization, an
Armenian-American organized crime enterprise engaged in a
wide range of criminal activity, including a $100 million
Medicare fraud billing ring)Criminal fine and forfeiture of
$150 million
11
Hospital Kickbacks and Unnecessary Services
• Sacred Heart Hospital
— CEO, CFO, five physicians charged in April 2013
— Allegations of kickbacks
— Allegations of unnecessary services (e.g., tracheotomies)
Physician Unnecessary Services
• John McLean, MD
—Maryland interventional cardiologist
— Unnecessary stents
— April 2013 – Fourth Circuit affirms conviction
12
WellCare
• Managed care corporation entered into DPA and FCA settlement
in May 2009 for scheme to defraud Florida Medicaid
• Four executives convicted in June 2013
— CEO
— CFO
— VP of Subsidiary
— VP of Medical Economics
13
14
31 U.S.C. §3729 et seq.
Civil statute
Initially enacted in 1863 to combat fraud, waste and
abuse in Civil War effort
Department of Justice has responsibility for enforcing
15
752 new qui tam matters filed
Total federal health care recoveries under the FCA
exceeded $2.5 billion
• $1.8 billion from alleged false claims for drugs and medical
devices reimbursed under Federal health care programs
• Additional $443 million for state Medicaid programs
Total reward paid to qui tam relators in health care
cases was $345 million
19 16
Two basic categories:
• Claims were false on their face (e.g., items not delivered, services not performed)
• Claims were not false on their face BUT submitter violated a separate statute,
regulation or contractual term with which compliance was a condition of payment
— The underlying violation renders the claim false or fraudulent, thus giving rise to
the FCA violation
Examples of other health care statutory violations that have provided the
predicate to FCA violations:
• Antikickback Statute
• Stark Law
• Federal Food Drug & Cosmetic Act
17
Hot areas of enforcement
• Pharmaceutical manufacturers, esp. off-label promotion and
kickbacks
• Devices, esp. kickbacks
• Inpatient/outpatient hospital
• Hospice (patients’ medical eligibility)
• Financial relationships with physicians (kickbacks and Stark
Law, esp. in Medicaid)
• Individuals
18
Pfizer (Wyeth), December 2012, $55 million
• Off-label promotion resulting in false claims to Medicare and Medicaid
• Allegation: promotion of Protonix for all forms of gastro-esophageal reflux
disease (GERD) although drug was approved by FDA only for short-term
treatment of erosive esophagitis–a condition associated with GERD
Hospice of Arizona and related entities, March 2013, $12 million
• Resolved allegations that it submitted claims for ineligible hospice services
Shands Teaching Hospital & Clinics Inc., Shands Jacksonville Medical Center
Inc. and Shands Jacksonville Healthcare Inc. , August 2013, $26 million
• Resolves allegations that six of its health care facilities submitted false claims to
Medicare, Medicaid and other federal health care programs for inpatient
procedures that should have been billed as outpatient services
19
Intermountain Health Care, April 2013, $25.5 million
• Based on self-disclosure
• Stark and FCA violations (employment agreements under which physicians
received bonuses that improperly took into account the value of some of their
patient referrals; and office leases and compensation arrangements)
C.R. Bard, May 2013, $48.26 million
• Allegedly paying kickbacks to physicians and/or customers to increase sales of
brachytherapy seeds (grants, guaranteed minimum rebates, conference fees,
marketing assistance, free medical equipment)
• No CIA, no release from HHS-OIG
20
August 2012, prominent Houston radiologist paid $650K to
resolve claims he paid illegal compensation to physicians to
induce them to refer patients to imaging center he owned and
operated. Agreed to voluntary exclusion from Medicare and
Medicaid for 6 years.
February 2013, prominent Florida dermatologist agreed to pay
$26.1 million to resolve allegations that he improperly accepted
remuneration from clinical laboratory. Agreed to 5-year
exclusion.
21
U.S. ex rel. Drakeford v. Tuomey, May 2013, Jury finds FCA
liability based on Stark violations and $39 million in damages.
Gonzalez v. Fresenius Med. Care N.A., 689 F.3d 470 (5th Cir. 2012)
– JMOL for defendants, jury verdict for defendants, sanctions
against relator’s counsel.
United States ex rel. Jamison v. McKesson Corp., 2012 U.S. Dist.
LEXIS 142078 (N.D. Miss. Sept. 28, 2012) – after bench trial,
court found govt failed to meet burden of proof that defs.
violated AKS or FCA.
22
U.S. ex rel. Carter v. Halliburton Co., 710 F.3d 171 (4th
Cir. 2013) – Wartime Suspension of Limitations Act
United States of America v. BNP Paribas SA et al., Civil
Action No. H-11-3718, 2012 U.S. Dist. LEXIS 110293
(S.D. Tex., August 6, 2012), motion for interlocutory appeal
denied, United States v. BNP Paribas SA, 2012 U.S. Dist.
LEXIS 143890 (S.D. Tex., Oct. 4, 2012)
23
U.S. ex rel. Williams v. Renal Care Group, Inc., 696 F.3d 518 (6th Cir. 2012) –
creating wholly-owned subsidiary to take advantage of loopholes in Medicare
regulations to increase profits did not violate FCA, where no evidence of
reckless disregard of falsity
U.S. ex rel. Little v. Shell Expl. & Prod. Co., 690 F.3d 282 (5th Cir. 2012) – federal
employees have standing as relators even where learned of alleged violations in
course of official duties.
Fresenius Med. Care Holdings, Inc. v. U.S., 2013 U.S. Dist. LEXIS 66234 – amount
of FCA settlement considered penalties for tax purposes
U.S. ex rel Hartpence v. Kinetic Concepts, Inc., 2013 U.S. Dist. LEXIS 74833 (C.D.
Cal.) – relator’s counsel disqualified for using privileged documents in pleadings
24
U.S. ex rel. Hobbs v. Medquest Assocs., 711 F.3d 707 (6th Cir. 2013)
– dismissed FCA claims where IDTF violated conditions of
participation but not conditions of payment (use of physician’s
old billing number instead of getting new IDTF billing number,
and direct supervision by physicians other than those identified
on enrollment forms)
U.S. ex rel. Foglia v. Renal Ventures Mgmt., LLC, 2012 U.S. Dist.
LEXIS 139160 (D. N.J. 2012) – court dismissed claim alleging
inadequate staffing since staffing requirements are conditions of
participation not conditions of payment.
25
U.S. ex rel. Osheroff v. Tenet Healthcare Corp., 2012 U.S.
Dist. LEXIS 96434 (S.D. Fla. 2012) and 2013 U.S. Dist.
LEXIS 44235 (S.D. Fla. 2013) – Relator alleges violations
of Stark and AKS rendered Medicare and Medicaid
claims false under FCA.
26
U.S. ex rel. Keltner v. Lakeshore Med. Clinic, Ltd., 2013 U.S. Dist.
LEXIS 44640 (E.D. Wis. 2013) – Relator stated a claim under
reverse false claim provision by alleging she notified defendant
of billing errors and defendant took no corrective action.
U.S. ex rel. Osheroff v. Tenet Healthcare Corp., 2013 U.S. Dist.
LEXIS 44235 (S.D. Fla. 2013) – relator must identify particular
facts showing that defendant owed an obligation to pay money
to govt and made a fraudulent statement to avoid or decrease
that obligation.
27
Numerous states have implemented their own FCAs
Some state FCAs approved by HHS-OIG for incentive
funding
Increased state participation in joint federal/state cases
Increased state-only enforcement actions
March 2013 “Updated OIG Guidelines for Evaluating
State False Claims Acts”
28
29
Updated Special Advisory Bulletin
Effect of Exclusion
Screening Best Practice:
— Pre-hiring/contracting, and
— Monthly
List of Excluded Individuals and Entities
Additional Updates to LEIE
National Provider Identifiers
Waivers
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Entities
• Primary Tool to Promote Future Compliance
• Individual Board/Management Responsibility
• New Provisions
Individuals
• Exclusion is More Likely
• Enhanced Audits
31
Sources of CMPs:
• Within OIG (OI, OAS)
• CIA and Self-Disclosure Spin Offs
• Competitor/Patient Complaints
False/Fraudulent Billing
Overcharging Beneficiaries
32
Physician Recipients of Kickbacks
Payors of Kickbacks
Unlicensed Physicians
Employment of Excluded Persons
33
Advisory Opinions
• 13-03. Potential violation for clinical laboratory to provide
assistance to physicians establishing their own laboratories that
would bill only non-FHCPs, in sponsoring clinical laboratory’s
building and potentially using sponsoring clinical laboratory’s
personnel.
• 13-19. Permitted patient assistance programs that provide
funding for premium assistance and certain other medical
expenses to patients with specific disease in financial need.
Special Fraud Alert on PODs
34
Enforcement of CIA Terms: enforcement of agreement
between OIG and entity
Resolution of Reportable Events: combination of
notification and mandatory disclosure with benefits of
the Self-Disclosure Protocol
35
Stipulated Penalties:
• Failure to submit report
• Failure to screen Covered Persons
• Failure to report a Reportable Event
• Failure to appoint IRO/Monitor
• False Certification
Specific Enforcement
Exclusion:
• Entities can be excluded for complete failure to implement the CIA.
36
Substantial Overpayments
Probable violation of law applicable to Federal health care program for which penalties or exclusion is authorized and Employment or contracting with an Ineligible Person:
• Notice
• Explanation of cause
• Root cause analysis
• Damages calculation, if applicable
Employment or contracting with an Ineligible Person
Filing of a bankruptcy petition
If OIG determines that a CMP is appropriate, they will apply same standards as in the Self-Disclosure Protocol
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39
Increased use of suspensions
Use of new provider moratoria
Contractor efforts against fraud
• RACs
• ZPICs
40
41
Patient Protection and Affordability Care Act (PPACA), March, 2012. “Health Reform Act,” “Affordable Care Act,” or the “ACA”
Ambitious legislation dealing with:
• Guaranteed availability and renewablilty of coverage, Sec. 2701,2703
• Prohibits preexisting condition exclusions, Sec. 2704
• Prohibits discrimination based on health status, Sec. 2705
• Requires coverage of defined essential benefits, Sec. 2707
• Prohibits excessive waiting periods, Sec. 2708
• National strategy to improve quality and ensure access
• Community prevention and wellness programs
• Removing barriers to wellness and immunizations
• Increasing access to preventive services
• Ensuring access to others (i.e. Rural protections, ambulance)
• Support for Prevention and Innovation
42
Enhanced Enforcement Provisions
• Enhanced Screening and other Enrollment Requirements
• Increased Coordination of Investigation
• Increased Data Sharing
• Enhanced Administrative Authorities both for OIG and Contractors
• New DME requirements
• New Investigative Resources
• Amendments to Criminal law making it easier to prove violations of
the Health Care Fraud and Anti-Kickback Statutes
• Expanded Focus on the Recovery of Overpayments
43
1. Overpayment defined broadly: Virtually anything a person receives or
retains that he is not entitled to.
2. ALL overpayments must be reported within 60 days of its
“identification” (or the cost report is due, if applicable) with an
explanation, the remedial actions taken, and repayment.
3. An overpayment that is not reported and repaid becomes a legal
“obligation” to the government (as defined in FERA).
4. The “knowing” failure to repay such an “obligation,” regardless of
whether it was the result of an innocent mistake or an intentional act, is
legally the same as if the money was obtained by fraud.
5. There is no need for the government to prove that there was a specific
intent to defraud.
44
Intended to give CMS’ views on the important questions arising out of
Section 6402 such as:
• What has to be reported and when?
• When is a claim “identified”?
• What is the scope of the duty to investigate?
THE OPENING PARAGRAPH CONTAINS THIS ADMONITION:
“… we remind all stakeholders that even without a final regulation they are subject to
the statutory requirements found in section 1128J(d) of the Act and could face
potential False Claims Act liability, Civil Monetary Penalties Law liability, and exclusion from
Federal health care programs for failure to report and return an overpayment.”
45
What must be reported? According to CMS, virtually everything:
• Covered services or cost report errors
• Duplicate payments or those in excess of the allowable
• Incorrect service date or incorrect CPT code
• Insufficient documentation or lack of medical necessity
When must it be reported? Provider has 60 days to:
• Diligently conduct the investigation, and reports and return any resulting overpayments
• If the provider fails to make any reasonable inquiry into the complaint, the provider may be
found to have acted in reckless disregard or deliberate ignorance of any overpayment.
46
The guidance articulates a strong obligation to investigate and report:
Equates “knowledge of overpayment with “knowledge” under the FCA.
• “Failure to make a reasonable inquiry, including failure to conduct such inquiry with all
deliberate speed after obtaining the information, could result in the provider knowingly
retaining an overpayment because it acted in reckless disregard or deliberate ignorance
• For example, a provider that receives an anonymous compliance hotline telephone complaint
about a potential overpayment has incurred an obligation to timely investigate that
matter.
Proposes a 10 year look back and reopening period
Self reporting through the existing contractor mechanisms:
• How the error was discovered; full extent of problem, amount of overpayment, how arrived out
(statistical sample?)
• corrective action plan
• Whether currently under (CIA) with the OIG or is under the OIG Self-Disclosure Protocol;
47
CMS is required to estimate the cost of the regulation and
calculates it based on the following assumptions:
• Approximately 125,000 providers and suppliers (roughly 8.5 percent of
the total) would report 3 – 5 overpayments a year
• It will “take a provider or supplier approximately 2.5 hours to complete
the applicable reporting form and return an overpayment”
• The reports cost less than $100 on average! They will be done mainly
by “(1) accountants and auditors (external and in-house); and (2)
miscellaneous in-house administrative personnel” at a cost of about
$33.15 per hour for the accountants and auditors and $16.99 an hour for
the others.
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Understand the rules that govern your business
• Laws, regulations, and case holdings
• HHS-OIG notices and fraud alerts
• CMS and Contractor notices and publications
Rules governing reimbursement: Coding and billing interpretations, LCDs,
NCDs and contractor publications
Ethical standards promulgated by the professional boards
STRATEGIES FOR IMPLEMENTING
COMPLIANCE PLANS: Start by Reviewing the
Applicable Legal Ethical and Professional
Standards
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GENERAL RISK AREAS
Employment of excluded individuals is a “hot button” issue
Patient privacy concerns and HIPAA violations require constant attention
In such a heavily regulated industry, recognizing that rules can (and
probably will) be inadvertently broken
• Thus, an intent to follow the rules, and the documentation of both
that intent and the efforts to comply are critical
Being alert that relationships and practices are under constant scrutiny and
viewing them
The risk of “waiting” has increased with the ACA. Problems never get
better over time
ADRESSING PROBLEMS:
Identify General and Specific Risk Areas
50
SPECIFIC RISK AREAS FOR YOUR CLIENT
Increasingly stringent requirements for patient eligibility for certification and
recertification
Special or unusual demands for documentation
Is there susceptibility to allegations about patient care?
Are there potential Stark and Anti-Kickback issues?
Are there risks that employees will want to help either the provider or the clients
they service so badly that they might consider bending the rules
Almost every FCA case is brought by a former employee
ADRESSING PROBLEMS:
Identify General and Specific Risk Areas
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DO A “GAP” ANALYSIS
Compare the baseline requirements for conducting your business with your
actual practices and evaluate the “GAP” between them
• After comparing these two sets of practices (ideal / legal vs. actual),
determine if there are any deficiencies (such as overpayments or
improper business practices)
• Identify your risk areas and compare how you handle them with
existing guidance and standards in the industry
ADDRESSING PROBLEMS:
Compare Your Client’s Business Model and
Practices to Others Similarly Situated
52
CONDUCT AN AUDIT
After identifying applicable regulatory/ statutory requirements, conduct an audit
of your Coding, Billing, Operations and Business Practices
Review all your coding and billing over the last 30 / 60 / 90 days
• Frankly assess your coding and billing practices
• Ask whether your documentation complies appropriate guidelines, such
as LCDs, NCDs or E/M Guidelines? If not, why not?
• Identify the cause of your deficiencies
Evaluate leases, contracts and other business relationships to determine if they
comply with Stark and Anti-Kickback laws.
Consider if there are other laws governing your business practices.
ADDRESSING PROBLEMS:
Compare Your Client’s Business Model and
Practices to Others Similarly Situated
53
GOING FORWARD, START WITH A VIABLE COMPLIANCE PLAN
Designating a Compliance Officer or contact
Implementing compliance and organizational standards
Conducting appropriate training and education
Conduct internal monitoring and auditing
Respond appropriately to detected offenses
Develop corrective action
Developing open lines of communication
Enforce disciplinary standards through well-publicized guidelines
Develop a mechanism for monitoring changes in law, policies and standards.
RESPONDING TO WHAT HAS BEEN FOUND:
Fix the Problems Identified and Create a Viable
Compliance Plan to Prevent their Reoccurrence
54
GOING FORWARD, WATCH FOR THE RISK AREAS
Medicare laws, regulations, rules, NCDs, LCDs, etc. are not static. You need to
periodically review the website of your Medicare Administrative Contractor for
changes.
Be prepared to implement a corrective action plan to address identified changes.
Read your private payer contracts each and every year. If you don’t understand a
provision, call the payors.
Stay current – attend conferences like this one and other trainings offered by
contractors, medical education companies and associations
Review HHS-OIG fraud alerts
Keep up with concerns raised by fellow Compliance Officers
Follow the government’s enforcement efforts
ADRESSING FUTURE PROBLEMS:
YOUR COMPLAINCE PLAN SHOULD BE A
MEANINGFUL AND LIVING DOCUMENT
55
FIX THE PROBLEMS YOU FIND
After identifying the problems, take the next step – FIX IT!
If you find overpayments, deal with them. This can be tricky as there are different
self-reporting formats, but it must be done.
• OIG has its own self reporting protocol
• DOJ has a self reporting protocol
• Each Contractor has its own self reporting protocol.
• All of which have different benefits and purposes
If you find questionable or non-compliant leases, fix them or get an opinion
• CMS has a self reporting protocol for Stark Issues
If you uncover questionable practices or relationships, fix them or seek advice as
to whether or how they need to be fixed
ADRESSING PROBLEMS:
PAST AND PRESENT
56
The “threat” of a False Claims Act case, even if completely without
substance, presents a real and present threat to every health care provider
This is particularly so now that overpayments can easily be converted into
“obligations” and “false claims”
The best defense is a commitment to compliance and a proactive
approach to issues and concerns
Identifying, reporting and fixing problems – however painful – is better
than trying to explain or defend actions that ignore or fail to acknowledge
shortcomings
Even though the False Claims Act does not require an “intent to defraud,”
there still must be a “knowing” submission or a willful disregard of a false
claim – and a commitment to compliance can strongly suggest otherwise
IMPORTANCE OF COMPLIANCE
57
58
FCA Reverse False Claims – 31 USC 3729(a)(1)(G)
• Cannot knowingly conceal or knowingly and improperly
avoid or decrease an obligation to pay or transmit money or
property to the Government
60-Day Repayment Rule ACA 6402(a)
• Medicare and Medicaid
• Report and Repay within 60 days of identification
59
HHS-OIG Self-Disclosure Protocol
CMS Self-Referral Disclosure Protocol
DOJ (Main)
USAO
State (for Medicaid)
Report and Repay to Contractor
60
Original OIG Protocol - 1998
Over 800 Disclosures Resolved for Over $280M
Protocol Updated April 2013
• Consolidates and Updates OIG Guidance
• Expectations
• Benefits
• Process
• Types of cases
61
60-day reporting and repayment requirement under
ACA, FCA triggered whenever provider identifies an
overpayment
More than mere repayment may be advisable when:
• Evidence of knowing/intentional misconduct
• Pattern of false/inaccurate claims
• Stark Law violation (with or without knowledge)
• Likelihood of whistleblower activity
62
Opportunity to be the first to introduce the situation
to enforcers (versus defending later)
Greater control over process
Reduce defense expenses
Reduce financial exposure
• FCA multiplier reduced
• Stark Law resolved at less than overpayment amounts
• Reduce criminal penalty if applicable under USSGs
Obtain FCA release, eventually barring relator actions
63
Lack of predictability
• Reaction of govt entity to which disclosure is made
• What agencies will become involved
• Resolution amount
64
HHS-OIG Self-Disclosure Protocol
CMS Self-Referral Disclosure Protocol
DOJ (Main)
USAO
State (for Medicaid)
Report and Repay to Contractor
65
CMS Voluntary Self-Referral Disclosure Protocol
(SRDP)
• Mandated by PPACA
• Issued 9/23/2010, revised 5/6/2011
• Establishes process to self-disclose actual or potential
violations of the Stark Law ONLY
• Disclosure tolls 60-day rule’s repayment obligations
• Settlement ranges over past year: $760 to $584,700
66
FCA Provisions
• No DOJ protocol for self-disclosing FCA
violations
• FCA allows imposition of damages multiplier at
doubles instead of trebles
• Must report within 30 days of discovering
misconduct
67
Laura Laemmle-Weidenfeld
Patton Boggs, LLP
202.457.6542
Paul S. Weidenfeld
Liles Parker, PLLC
(202) 298-8750
69