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© 2015 Epstein Becker & Green, P.C. | All Rights Reserved. ebglaw.com
The Health Plan Board’s Role in
Managing Risk
Carrie Valiant
Epstein Becker Green
June 7, 2016
© 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com
Presented by
Carrie Valiant
Senior Member of the Firm, Epstein Becker Green
cvaliant@ebglaw.com
202-861-1857
2
© 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com
Agenda
3
1. Board and Fiduciary Responsibilities in
Enterprise Risk Management/Compliance
--Example: Strategic Partnerships and Alliances
2. Enterprise Risk Management: The Next Step
3. Establishing Enterprise Risk Management
Priorities
4. Key Risk Areas for Health Plans
(High Likelihood—High Significance)
5. Preparing Your Health Plan to Stay Ahead
© 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com
Board Involvement
 Not For Profit Boards
• Street Law
• Washington Lawyers Committee
• WBL – Women Business Leaders of the U.S. Healthcare Industry
• Health Care Industry Access Initiative
 For Profit Boards
• Epstein Becker & Green, P.C.
 Legal
• Conducted Board-led investigations of potential Board and CEO misconduct
(compensation and conflict irregularities)
• Board training regarding compliance
• Structural recommendations for Board oversight of compliance and risk
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Board and Fiduciary
Responsibilities in
Enterprise Risk
Management/Compliance
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Board Obligations Generally Regarding Compliance
Business Judgment Rule (“BJR”)
 Presumption that Board members fulfill their fiduciary duties when they act
on an informed basis and in good faith that a certain action is in the
corporation's best interest
 In re Walt Disney, 906 A.2d 27 (Del. 2006)
• Issue of potentially unreasonable executive compensation
• Directors had not breached their fiduciary duties of good faith and loyalty, even
though the court stated that the board’s actions may have been below best
corporate practices
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Board Obligations Generally Regarding Compliance
Duty of Care/Duty of Loyalty
 Board obligation to act in “good faith” and loyal to the Corporation’s interest
 In re Caremark International, 698 A.2d 959 (Del. Ch. 1996)
“[The Court is] of the view that a director’s obligation includes a duty to attempt in
good faith to assure that a corporate information and reporting system, which the
board concludes is adequate, exists, and that failure to do so under some
circumstances may, in theory at least, render a director [personally] liable for losses
caused by noncompliance with applicable legal standards. . . .
Obviously the level of detail that is appropriate for such an information system is a
question of business judgment.”
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What is a Corporate Compliance Program?
 A corporate compliance program is a mechanism to detect and
prevent improper behavior in the workplace
 Corporate compliance programs can:
• Demonstrate to employees and the community that the organization is
committed to honesty and acting responsibly;
• Encourage employees to report potential problems
• Create a process by which organizations can identity and prevent criminal
and unethical conduct
• Reduce the organization’s (and its Board’s) exposure to civil damages and
administrative remedies, such as exclusion from participation in federal
and state healthcare programs
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7 Elements
Written Policies,
Procedures and
Standards of
Conduct
Compliance Officer
and Compliance
Committee
Effective Training and
Education
Effective Lines of
Communication
Internal Monitoring
and Auditing
Disciplinary
Guidelines
Responding Promptly
to Detected Offenses
and Corrective Action
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Mandatory Compliance Requirements
TREND TOWARD MANDATORY COMPLIANCE PROGRAMS
 ACA grants the DHHS the authority to require providers and suppliers to
establish a compliance program as a condition of enrollment in the
Medicare, Medicaid and CHIP programs
• Calls for the Secretary to act in consultation with the OIG to establish core
elements for provider compliance programs
 CMS required implementation of compliance programs for Part C (Medicare
Advantage) and Part D (Prescription Drug) plans in 2011 (42 C.F.R. §§
422.503(b)(4)(iv) and 423.504(b)(4)(vi))
• These compliance requirements are codified at Requirements more
stringent than typical compliance program requirements but are still
founded in the 7 Elements
 Qualified Health Plans offered on an exchange are required to have an
effective compliance program (45 C.F.R. §156.715)
• QHP must attest that it has a compliance plan that meets seven specific
elements
• QHPs are required to submit a copy of the compliance plan as part of the
application process for certification
 Medicaid Final Rule also requires mandatory compliance program
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OIG Expectations Regarding Board Involvement
in Compliance
 Practical Guidance for Health Care Governing Boards on Compliance
Oversight, April 20, 2015
 Cultivate a Culture of Compliance with Health Care Laws: A Toolkit for Health
Care Boards, February 27, 2012
 The Health Care Director’s Compliance Duties: A Continued Focus of
Attention and Enforcement, August 29, 2011
 An Integrated Approach to Corporate Compliance: A Resource for Health
Care Boards of Directors, July 1, 2004
 Corporate Responsibility and Corporate Compliance: A Resource for Health
Care Boards of Directors, April 2, 2003
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OIG Expectations RegardingBoard Involvement
in Compliance
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Expectations of Board Members
 A Board Member is not expected to be a lawyer or an
expert on health care laws nor is expected to run the
compliance program
 But Board Members are expected to:
• Generally understand the Federal healthcare program
requirements that govern health plan operations and
• To make reasonable inquiries to health plan management
regarding the effectiveness of the Compliance Program
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Examples of Structural Questions
 How is the compliance program structured and who are the key
employees responsible for its implementation and operation?
 How is the Board structured to oversee compliance issues?
 How does the organization’s compliance reporting system
work?
 How frequently does the Board receive reports about
compliance?
 Does the compliance program address the significant risks of
the organization?
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Examples of Operational Questions
 How has the Code of Conduct been incorporated into corporate
policies across the organization?
 Has management taken affirmative steps to publicize the
importance of the Code to all its employees?
 Does the Compliance Officer have sufficient authority to
implement the compliance program?
 How is the Board kept apprised of significant regulatory and
industry developments?
 Does the organization have policies that address the
appropriate protection of whistleblowers?
 Are the board and senior management working to foster a
culture of compliance
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Corporate Integrity Agreements (CIAs)
OIG EXPECTATIONS FOR BOARDS
 Board of Directors required to meet bimonthly to review the
compliance program
 Must retain a compliance expert to assist the board for the
duration of the CIA
 Must adopt unanimous resolution for each reporting period
summarizing the review of the compliance program
• Must certify to a reasonable inquiry and to implementation of
an effective compliance program that meets Federal health
care program requirements
• If the board is unable to do this, it must explain why to OIG
 Penalties for false certification
Source: Halifax Hospital Medical Center (non-profit hospital system) CIA, Mar. 10, 2014.
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CMS Expectations of Health Plan Boards
 “The … governing body (e.g., Board of Directors or Board of Trustees) must
exercise reasonable oversight with respect to the implementation and
effectiveness of the sponsor’s compliance program…When compliance
issues are presented to the sponsor’s governing body, it should make further
inquiry and take appropriate action to ensure the issues are resolved.
 “[E]nsure that CMS is able to validate, through review of governing body
meeting minutes or other documentation, the active engagement of the
governing body in the oversight of the Medicare compliance program. A
governing body that is appropriately engaged asks questions, requires
follow-up on issues and takes action when necessary.”
Medicare Managed Care Manual, Compliance Program Guidelines, Section
50.2.3 – Governing Body
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CMS Expectations of Boards Regarding FDRs
 Governing bodies should collect and review measurable evidence that the
compliance program is detecting and correcting Medicare program
noncompliance on a timely basis.
 Among the enumerated indicators of an effective compliance program are
listed:
• Monitoring to track FDR compliance
• Actions taken in response to compliance reports submitted by FDRs
 Mantra –
• You can contract away health plan activities, but you
can’t contract away health plan responsibilities.
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CMS Expectations Regarding FDRs
 Health plans typically carry out a substantial portion of their operations
through the use of First tier, Downstream, and Related Entities.
 “The [health plan] sponsor maintains the ultimate responsibility for fulfilling
the terms and conditions of its contract with CMS, and for meeting the
Medicare program requirements. Therefore, CMS may hold the sponsor
accountable for the failure of its FDRs to comply with Medicare program
requirements.”
• Medicare Managed Care Manual, Section 40 – Sponsor Accountability for and
Oversight of FDRs
 Health plans must oversee FDR compliance with Medicare Part C and D
requirements
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 CMS lists various functions that are considered FDRs (and for which health
plans are responsible.)
 Examples of these functions --
• Sales and marketing;
• Utilization management;
• Quality improvement;
• Applications processing;
• Enrollment, disenrollment, membership functions;
• Claims administration, processing and coverage adjudication;
• Appeals and grievances;
• Licensing and credentialing;
• Pharmacy benefit management;
FDRs
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 FDR Examples, continued
• Hotline operations;
• Customer service;
• Bid preparation;
• Outbound enrollment verification;
• Provider network management;
• Coordination with other benefit programs such as Medicaid, state pharmaceutical
assistance or other insurance programs;
• Entities that generate claims data; and
• Health care services.
FDRs, continued
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CMS Diagram – Part C (MA)
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• CMS authority to take enforcement or contract actions against Medicare plan sponsors
– Civil Money Penalties (CMP)
– Intermediate Sanctions (i.e., suspension of enrollment, marketing, payment)
– Termination
• Over 100 enforcement / contract actions since 2008
• Responding to sanctions / violations requires submission and implementation of Corrective
Action Plans (CAPs):
– Identification of Violation
– Root Cause Analysis
– Beneficiary Impact Analysis
– Description and Explanation of Corrective Action
– Description of / Explanation of Beneficiary Remediation
• CMS issued first sanction related to compliance program violations
Part C and Part D Enforcement Actions
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Intermediate Sanctions
• CMS imposition of intermediate sanctions on Part D plans that fail to operate in
accordance with CMS requirements
• Suspension of marketing and enrollment in response to:
Plan A (May 28, 2014)
• Applied unapproved utilization management
practices in formulary
• Denial letters lacked adequate rationale or
contained inaccurate information
• Failure to obtain additional prescriber
information to make clinical decisions
• Failure to properly oversee delegated entity, and
other violations
Plan B (Aug. 11, 2014)
• Failure of medical director to oversee coverage
determination appeals effectively
• Misclassified coverage redetermination
requests as grievances
• Applied unapproved quantity limits in
formulary, and other violations
Plan C (Jan. 21, 2016)
• Failure to properly oversee delegated entities responsible for processing Part C organization
determinations, appeals and grievances
• Failure of compliance officer to provide updates on results of monitoring, auditing, and compliance
failures to senior leadership
• Failure to establish formal risk assessment program
• Failure to maintain documentation of identified deficiencies and corrective actions taken
• Failure to develop and implement an effective system for corrective actions require of first tier entities
• Untimely notification to beneficiaries/providers of determinations as part of expedited organization
determination and reconsideration requests
• Applied unapproved quantity limits in formulary, and other violations
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Health Plan/Health System Compliance Programs
 CMS allows health plan sponsors or their parent organizations to run the
health plan’s compliance program
 Where that parent organization is a health system, is that a good idea?
 Key differences between health system/health plan compliance obligations
• Health system compliance obligations are voluntary (unless the health system is
under a CIA)/health plan compliance programs are mandatory
• Health system compliance programs are largely administrative/health plan
compliance programs are expected to assure operational compliance
• Health system compliance programs use different verbiage than health plan
compliance programs
oFraud and abuse vs. fraud, waste and abuse (FWA)! (Makes a difference during
a site visit/survey)
• Health system risks are different from health plan risks
oCMS Sanctions versus FCA investigations
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Health Plan/Health System Compliance Programs
 Necessary Firewalls?
• Consider also firewalls for antitrust purposes in a context in which
operational compliance is key and you are responsible for downstream
entity (i.e. provider) compliance
• Will health system compliance program be monitoring operations of
competing providers?
 Consider parent compliance program assuming some
compliance program functions where efficiencies can be gained
(i.e., exclusion checks, etc.) but having separate compliance
officer infrastructure.
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Enterprise Risk Management:
The Next Step
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What is Enterprise Risk Management?
 According to COSO*, it is –
• A process,
• effected by an entity's board of directors, management, and other
personnel,
• applied in strategy setting and across the enterprise,
• designed to identify potential events that may affect the entity,
• and manage risk to be within its risk appetite,
• to provide reasonable assurance regarding the achievement of entity
objectives
*Committee of Sponsoring Organizations of the Treadway Commission
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Enterprise Risk Management Structure –
Break Down the Silos!
Enterprise
Risk
Management
AuditCompliance
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5 Best Practices for an Effective
Enterprise Risk Management Process
1. Establish a comprehensive ERM policy
• Incorporate all risk functions including compliance, audit
• Avoid silos to optimize all metrics in decision-making
2. Understand and assess risk as it relates to the Company’s
immediate and longer term objectives, and consider risk
management efforts
• Encourage open discussion of “what keeps people awake at night”
• Incorporate ERM into the strategic planning process
--Sources: the American Institute of CPAs (AICPA), “Top 10 ‘Next’ Practices for Enterprise Risk Management,”
http://www.academia.edu/8716339/Top_Ten_Next_Practices_for_Enterprise_Risk_Management_2010_AIC
PA_Survey_Results_Table_of_Contents_Top_Ten_Next_Practices_for_Enterprise_Risk_Management;
McKinsey & Co., From Compliance to Value Creation: The Journey to Effective Enterprise Risk Management for Insurers
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5 Best Practices for an Effective
Enterprise Risk Management Process
3. Create a partnership with between ERM and business
• Use ERM to guide the behavior and thought process of decision-makers
• Communicate regularly, thoroughly, top to bottom, bottom to top and
across the organization
4. Establish the right monitoring processes to make sure risk
mitigation activities operate as designed
• Regularly track and monitor the risks facing the organization both
internally and externally
5. Make ERM a top priority of the Board of Directors and senior
management
• Promote a risk-oriented culture (soft skills are important)
• Make risk part of your story of organizational value (public relations
strategy)
31
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Establishing
Enterprise Risk Management
Priorities
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Establishing Enterprise Risk Priorities:
Heat Map
33
Low
High
High
Significance
(financial, strategic, reputational, etc.)
Likelihood
(considering controls and inherent risks)
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Greater Connectivity, Higher Risk
 Greater interconnection and interdependency among health care entities
expand vulnerabilities, which affects any entity connected with the health
plan (vendors, suppliers, partners, customers)
 Lack of board room or senior management expertise often creates
challenges when overseeing risks and risk management efforts
34
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Interconnection & Integration
35
Insurance
Patients
Physicians
Health
Plans
Integrated
Delivery
PhysiciansHome
Health
PatientsMedical
Devices
Labs Insurance
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Management’s ERM Process
Regarding Strategic Partnerships and Alliances
36
 Definition of a strategic partner/alliance
• Company enters into a relationship with a third party to provide a unique
service or technology that is critical to the company’s strategy,
operations, and success
• Generally a longer term relationship
• Longer, more strategic, and greater impact than a normal vendor contract
 All health plans have a strategic partner or alliance
• FDRs are strategic partners
• Example: PBMs
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Potential Risks Regarding
Strategic Partnerships and Alliances
37
 Partnering for critical services leaves the Company with less control
• Potential impact on sales, operations, customer/member satisfaction, profitability,
and compliance
 Failure of partner to perform as expected would negatively impact
consultants/brokers/employers/employees/government relationships
 Company likely would be responsible for partner’s activities, even outside
the MA context
 Potential changes can occur at the partner
• Change in ownership or senior management
• Shift in strategy, products, or customer base
• Reputational issues
• Financial issues
© 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com
A Few Caveats About Using Heat Maps for
Compliance Purposes
 Everyone knows compliance is a high risk area in terms of significance
 BUT…No one ever thinks they are at high risk (i.e., likelihood) for a sanction!
 Why?
 EDI (Everybody’s Doing It)
• People assume everyone else’s reported struggles with compliance concerns
means they are not outliers
• But there is always a “first” when it comes to enforcement actions
• Examples – 2014 was first CMS Sanction; 2016 was first CMS Sanction with
Compliance-specific
 People assume that their policies and procedures, or the Compliance
Program generally, or their choice of a qualified, reputable FDR, are
sufficient to mitigate identified high risk areas.
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Heat Map: Enterprise Risk of Sanction
(from FDR Relationships)
39
Low
High
High
Significance
(financial, strategic, reputational, etc.)
Likelihood
(considering controls and inherent risks)
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Health Plan Areas of Vulnerability
 Items with direct beneficiary impact, including:
• Denial decisions
• Claims payment
• Grievances and appeals
 Marketing and Enrollment Practices – particularly agent misrepresentation
 Inappropriate Risk Adjustment and Misclassifications
 Defective Data or Bid Submissions (both incomplete and inaccurate
submissions)
 Direct and Indirect Remuneration Reporting and Characterization (drug
costs)
 Relationships with Providers and Downstream Contractors
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 Underutilization
 Financial incentives built into capitated rates
 Withhold or risk-sharing arrangements
 Discouraging treatment is prohibited
 Disallowing medically necessary covered services
 Doing business with excluded individuals
 Failure to pay providers
 Retaining overpayments collected from providers
 Plans may be held responsible for the actions of their
downstream contractors
Health Plan Areas of Vulnerability (continued)
Relationships with Providers and Downstream Contractors
41
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Preparing Your
Health Plan to
Stay Ahead of
Enterprise Risks
© 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com
Health Plans and Other Health Care Organizations
 Adopt a comprehensive ERM policy at the management and
board level
 Educate board management and employees frequently
 Consider adopting the 5 Best Practices for ERM
 Consider CMS relationship (Medicare/Medicaid) as one high risk
that deserves resources for risk management mitigation efforts
 Consider reviewing Strategic Partnerships and Alliances as one
high risk that deserves resources for risk management
mitigation efforts
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 Provide time to build the Board’s Federal Health Care
Program/CMS Literacy, as well as ERM
• Consider having a special committee or subcommittee address specific
enforcement actions/areas of vulnerability
 Provide regular reports to Board
• Determine risk and risk thresholds to be reported
• Evaluate risk management efforts
Addressing Risk in the Board Room
Putting Key Risks on the Board Agenda
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 Formulate strategic response plans
 Consider the role of Strategic Partners and Alliances in risk
management
 Create strategies that would confront the company’s worst
possible scenarios and protect its highest value targets
• From the perspective of the organization and external actors
 SEC Disclosure Considerations, if any or Bond Debt
Considerations
• Standard of materiality
 HHS OIG Compliance Considerations
Addressing Key Risks in the Board Room
Management Responsibilities
45
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Mitigating Risk Before a Sanction Occurs
 Proper Policies and Procedures
• Stay current on CMS priorities
• Refresh training programs
 Mock Audits
 Contracts with Downstream Vendors (PBMs, etc.)
• Plan is responsible for actions of downstream vendors
• Include rights for downstream audits and CAPs
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Mitigating Risk Before a Sanction Occurs
 Appropriate Self-Monitoring
• Regular internal audits
• Compliance Auditing and Monitoring (Effectiveness Reviews)
 Public Relations Firm
• Ready to activate for addressing press and member concerns
 Internal Response Plan
• Early and often CEO communication with CMS
• Special Committee of the Board
• Build Board expertise
47
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 Upfront Risk Mitigation Steps
• Conduct a thorough initial due diligence of the operational capabilities and
financial conditions of the strategic partner
• Understand the strategy of the partner to make sure there is a good strategic and
cultural fit for both partners and that they share a common goal
• Draft a strong contract that provides protection regarding governance,
performance expectations and standards, changes of ownership, dispute
resolution, exclusivity, potential indemnification, and other key issues
 Ongoing Risk Mitigation Steps
• Conduct regular reviews to ensure compliance and financial stability of partner
• Consider frequent on-site visits
• Build and maintain strong, mutually beneficial relationships
Mitigating the Probability or Impact of the
Risks Associated with Strategic Partnerships and Alliances
48
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 The Board of Directors engages in meaningful effort to review the adequacy of
existing compliance systems and functions
 The Compliance Officer reports periodically directly to the Board on activities and
status of compliance program, including issues investigated, identified and resolved
by compliance program
• Minutes are kept with sufficient detail to enable an auditor to see follow-through
• Executive Sessions with the Board?
 The Board of Directors receives compliance training
 The Board of Directors reviews and approves compliance training
 The Board of Directors reviews and approves new and updated policies
• A resolution is adopted by the Board approving policies
 The Board of Directors oversees that management consistently reviews and audits
risk areas, as well as develops, implements, and monitors corrective action plans
Mitigating Compliance Risks –
A Checklist for the Board
49
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Appendix – Key
Vulnerabilities for
Medicare
Advantage/Medicaid
Health Plans
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Marketing and Enrollment Practices
 Marketing practices of Medicaid and Medicare Managed Care
Organizations face increased scrutiny
 Concerns addressed in Medicare Marketing Guidelines include:
• Language and cultural competency
• Door-to-door solicitation
• In-home marketing appointments
• Cross-selling of non-healthcare related products
• Offering gifts or payments, including meals
• White coat / provider based marketing
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Marketing and Enrollment Practices
 Enrollment and disenrollment practices
 Managed Care Organization may not discriminate based on:
• Race, ethnicity, religion, gender, sexual orientation, health status,
geographic location, national origin, mental or physical disability, claims
experience, medical history, genetic information, or evidence of
insurability
 Plans are required to refrain from:
• Marketing only to healthy individuals (“cherry picking”)
• Avoiding individuals with a high risk for costly or prolonged treatment
needs (“lemon dropping”)
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Marketing and Enrollment Practices
 Amerigroup Case - United States, ex rel. Tyson v. Amerigroup
Illinois, Inc. (N.D. Ill)
• Jury awarded -- $334 million judgment
• Settlement -- $225 million plus a corporate integrity agreement
• Allegations that Amerigroup violated the FCA by systematically avoiding
enrolling certain patient groups in its Illinois Medicaid HMO
 Theories of the case included:
• Fraudulent inducement in misrepresenting to Illinois Medicaid
• Submission of certifications of compliance that implied non-discrimination
• Receipt of inflated capitation payments in violation of state and federal
False Claims Act provisions, based on false promises not to discriminate
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Inappropriate Risk Adjustment and
Misclassifications
 Medicare Modernization Act of 2003
• Hierarchical Condition Category Payment System
o Payments made to managed care plans based on Risk Adjustments
o Risk Adjustment Factors
o Plans with a healthier membership reimbursed less than “sick” membership
 Potential liability under False Claims Act
 45 Day CMS Payment Notices- CMS proposed that codes
derived from in-home risk assessments would not be accepted,
never finalized proposals.
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Inappropriate Risk Adjustment and
Misclassifications
Recent Settlements
 United States v. Walter Janke, MD, Lalita Janke and Medical
Resources, LLC (2012)
• Government sued under FCA for submission of upcoded diagnoses codes
to increase risk adjustment scores
• Settled with DOJ = $22.6 million
 United States and State of California ex rel. Swoben v. SCAN
Health Plan (2012)
• Relator alleged ScanHealth inflated risk adjustment scores
• Settled with DOJ = $3.82 million
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Inappropriate Risk Adjustment and
Misclassifications
United States ex rel. Olivia Graves v. Plaza Medical Group, Corp, Humana, Inc.,
Michael Cavanaugh, and Spencer Angel
• Allegations: Physician manipulated diagnostic codes to inflate Medicare
Part C capitation payments and that Humana was aware or should have
been aware of a significant increase in patients diagnosed with
diabetes/renal or peripheral circulatory problems.
United States of America ex rel. Jose R. Valdez v. Aveta, Inc.; MMM Healthcare,
Inc.; PMC Medicare Choice, Inc.; MSO of Puerto Rico, Inc.; MMM Holdings, Inc.
• Allegations: Diagnosis codes that were unsubstantiated by medical
records or by medical conditions of the Medicare beneficiaries. Internal
audit showed that over 2/3 of patient risks scores were unsupported by
medical documentation.
© 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com
Defective Data or Bid Submissions
Plans are responsible for complete and accurate bids to CMS.
 Incomplete Submissions – bids will not be accepted by CMS if any required
component is not submitted by deadline
 Inaccurate Submissions:
• “Clearly inaccurate” call into question sponsor’s ability to fully comply
with program requirements
• Sponsors submitting inaccurate Part D bids may receive a corrective
action plan or may have their bids denied
• CMS examples of “clearly inaccurate” information:
oA bid for an enhanced plan but not a basic plan
oA bid for a non-defined standard plan that does not meet Part D benefit
parameters
oAn incorrect crosswalk between the plan benefit package and formulary
© 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com
Defective Data or Bid Submissions
Inaccurate bids to CMS may trigger fraud enforcement
 All information that plan sponsors submit to CMS in connection
with a bid may provide the basis for a false claim action
• Plan sponsors “must certify (based on best knowledge, information, and
belief) that the information in its bid is accurate, complete, and truthful
and fully conforms with [submission requirements].”
 CMS audits at least one third of annual bid submissions to
protect against improper submissions
© 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com
Defective Data or Bid Submissions
 Amerihealth Mercy Health Plan paid over $2 million to Kentucky
Medicaid for falsely reporting its Health Effectiveness Data Set
(HEDIS) score for Cervical Cancer Screenings in order to obtain
bonus money from the Department of Medicaid Services.
 CareSource paid $26 million for allegedly submitting false data
that it provided screening, assessment, and case management
services to retain incentive portion of capitation payments.
 PacifiCare settlement for $87 million for allegedly including
unallowable items in calculation of ACR, including lobbying and
entertainment costs, costs of related organizations.
© 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com
Medical Loss Ratios
 Medical Loss Ratio rules require that insurers spend at least 85%
of large group premium revenue and 80% of small group and
individual policy premium revenue on:
• Medical care
• Healthcare quality improvement activities
 In 2012, Wellcare Health Plans agreed to pay $137.5 million to
the federal government and nine states to resolve four lawsuits
alleging FCA violations and enter into a five-year Corporate
Integrity Agreement.
• Some State Medicaid programs had MLR thresholds, e.g., Florida
established minimum MLR requirements for Medicaid premiums for
behavioral health services
© 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com
Relationships with Providers and Downstream
Contractors
Case Examples
 Keystone Mercy Health Plan – settlement for $5 million for allegedly
keeping overpayments it collected from providers instead of
refunding the State of Kentucky
 IntraCorp – settlement with 6 States and the Federal Government for
$3.15 million for alleged failure to provide adequate written
utilization review criteria to providers, as well as not providing
adequate quality and training assurance programs and other
utilization management inadequacies
 Tower Health – criminal charges stemming from allegedly siphoning
funds to affiliated entities instead of paying providers, falsification of
financial data.
© 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com
Presented by
Carrie Valiant
Senior Member of the Firm, Epstein Becker Green
cvaliant@ebglaw.com
202-861-1857
62

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The Health Plan Board’s Role in Managing Risk

  • 1. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. ebglaw.com The Health Plan Board’s Role in Managing Risk Carrie Valiant Epstein Becker Green June 7, 2016
  • 2. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Presented by Carrie Valiant Senior Member of the Firm, Epstein Becker Green cvaliant@ebglaw.com 202-861-1857 2
  • 3. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Agenda 3 1. Board and Fiduciary Responsibilities in Enterprise Risk Management/Compliance --Example: Strategic Partnerships and Alliances 2. Enterprise Risk Management: The Next Step 3. Establishing Enterprise Risk Management Priorities 4. Key Risk Areas for Health Plans (High Likelihood—High Significance) 5. Preparing Your Health Plan to Stay Ahead
  • 4. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Board Involvement  Not For Profit Boards • Street Law • Washington Lawyers Committee • WBL – Women Business Leaders of the U.S. Healthcare Industry • Health Care Industry Access Initiative  For Profit Boards • Epstein Becker & Green, P.C.  Legal • Conducted Board-led investigations of potential Board and CEO misconduct (compensation and conflict irregularities) • Board training regarding compliance • Structural recommendations for Board oversight of compliance and risk 4
  • 5. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. ebglaw.com Board and Fiduciary Responsibilities in Enterprise Risk Management/Compliance
  • 6. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Board Obligations Generally Regarding Compliance Business Judgment Rule (“BJR”)  Presumption that Board members fulfill their fiduciary duties when they act on an informed basis and in good faith that a certain action is in the corporation's best interest  In re Walt Disney, 906 A.2d 27 (Del. 2006) • Issue of potentially unreasonable executive compensation • Directors had not breached their fiduciary duties of good faith and loyalty, even though the court stated that the board’s actions may have been below best corporate practices 6
  • 7. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Board Obligations Generally Regarding Compliance Duty of Care/Duty of Loyalty  Board obligation to act in “good faith” and loyal to the Corporation’s interest  In re Caremark International, 698 A.2d 959 (Del. Ch. 1996) “[The Court is] of the view that a director’s obligation includes a duty to attempt in good faith to assure that a corporate information and reporting system, which the board concludes is adequate, exists, and that failure to do so under some circumstances may, in theory at least, render a director [personally] liable for losses caused by noncompliance with applicable legal standards. . . . Obviously the level of detail that is appropriate for such an information system is a question of business judgment.” 7
  • 8. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com What is a Corporate Compliance Program?  A corporate compliance program is a mechanism to detect and prevent improper behavior in the workplace  Corporate compliance programs can: • Demonstrate to employees and the community that the organization is committed to honesty and acting responsibly; • Encourage employees to report potential problems • Create a process by which organizations can identity and prevent criminal and unethical conduct • Reduce the organization’s (and its Board’s) exposure to civil damages and administrative remedies, such as exclusion from participation in federal and state healthcare programs 8
  • 9. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com 7 Elements Written Policies, Procedures and Standards of Conduct Compliance Officer and Compliance Committee Effective Training and Education Effective Lines of Communication Internal Monitoring and Auditing Disciplinary Guidelines Responding Promptly to Detected Offenses and Corrective Action 9
  • 10. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Mandatory Compliance Requirements TREND TOWARD MANDATORY COMPLIANCE PROGRAMS  ACA grants the DHHS the authority to require providers and suppliers to establish a compliance program as a condition of enrollment in the Medicare, Medicaid and CHIP programs • Calls for the Secretary to act in consultation with the OIG to establish core elements for provider compliance programs  CMS required implementation of compliance programs for Part C (Medicare Advantage) and Part D (Prescription Drug) plans in 2011 (42 C.F.R. §§ 422.503(b)(4)(iv) and 423.504(b)(4)(vi)) • These compliance requirements are codified at Requirements more stringent than typical compliance program requirements but are still founded in the 7 Elements  Qualified Health Plans offered on an exchange are required to have an effective compliance program (45 C.F.R. §156.715) • QHP must attest that it has a compliance plan that meets seven specific elements • QHPs are required to submit a copy of the compliance plan as part of the application process for certification  Medicaid Final Rule also requires mandatory compliance program 10
  • 11. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com OIG Expectations Regarding Board Involvement in Compliance  Practical Guidance for Health Care Governing Boards on Compliance Oversight, April 20, 2015  Cultivate a Culture of Compliance with Health Care Laws: A Toolkit for Health Care Boards, February 27, 2012  The Health Care Director’s Compliance Duties: A Continued Focus of Attention and Enforcement, August 29, 2011  An Integrated Approach to Corporate Compliance: A Resource for Health Care Boards of Directors, July 1, 2004  Corporate Responsibility and Corporate Compliance: A Resource for Health Care Boards of Directors, April 2, 2003 11
  • 12. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com OIG Expectations RegardingBoard Involvement in Compliance
  • 13. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Expectations of Board Members  A Board Member is not expected to be a lawyer or an expert on health care laws nor is expected to run the compliance program  But Board Members are expected to: • Generally understand the Federal healthcare program requirements that govern health plan operations and • To make reasonable inquiries to health plan management regarding the effectiveness of the Compliance Program 13
  • 14. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Examples of Structural Questions  How is the compliance program structured and who are the key employees responsible for its implementation and operation?  How is the Board structured to oversee compliance issues?  How does the organization’s compliance reporting system work?  How frequently does the Board receive reports about compliance?  Does the compliance program address the significant risks of the organization?
  • 15. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Examples of Operational Questions  How has the Code of Conduct been incorporated into corporate policies across the organization?  Has management taken affirmative steps to publicize the importance of the Code to all its employees?  Does the Compliance Officer have sufficient authority to implement the compliance program?  How is the Board kept apprised of significant regulatory and industry developments?  Does the organization have policies that address the appropriate protection of whistleblowers?  Are the board and senior management working to foster a culture of compliance
  • 16. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Corporate Integrity Agreements (CIAs) OIG EXPECTATIONS FOR BOARDS  Board of Directors required to meet bimonthly to review the compliance program  Must retain a compliance expert to assist the board for the duration of the CIA  Must adopt unanimous resolution for each reporting period summarizing the review of the compliance program • Must certify to a reasonable inquiry and to implementation of an effective compliance program that meets Federal health care program requirements • If the board is unable to do this, it must explain why to OIG  Penalties for false certification Source: Halifax Hospital Medical Center (non-profit hospital system) CIA, Mar. 10, 2014. 16
  • 17. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com CMS Expectations of Health Plan Boards  “The … governing body (e.g., Board of Directors or Board of Trustees) must exercise reasonable oversight with respect to the implementation and effectiveness of the sponsor’s compliance program…When compliance issues are presented to the sponsor’s governing body, it should make further inquiry and take appropriate action to ensure the issues are resolved.  “[E]nsure that CMS is able to validate, through review of governing body meeting minutes or other documentation, the active engagement of the governing body in the oversight of the Medicare compliance program. A governing body that is appropriately engaged asks questions, requires follow-up on issues and takes action when necessary.” Medicare Managed Care Manual, Compliance Program Guidelines, Section 50.2.3 – Governing Body 17
  • 18. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com CMS Expectations of Boards Regarding FDRs  Governing bodies should collect and review measurable evidence that the compliance program is detecting and correcting Medicare program noncompliance on a timely basis.  Among the enumerated indicators of an effective compliance program are listed: • Monitoring to track FDR compliance • Actions taken in response to compliance reports submitted by FDRs  Mantra – • You can contract away health plan activities, but you can’t contract away health plan responsibilities. 18
  • 19. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com CMS Expectations Regarding FDRs  Health plans typically carry out a substantial portion of their operations through the use of First tier, Downstream, and Related Entities.  “The [health plan] sponsor maintains the ultimate responsibility for fulfilling the terms and conditions of its contract with CMS, and for meeting the Medicare program requirements. Therefore, CMS may hold the sponsor accountable for the failure of its FDRs to comply with Medicare program requirements.” • Medicare Managed Care Manual, Section 40 – Sponsor Accountability for and Oversight of FDRs  Health plans must oversee FDR compliance with Medicare Part C and D requirements 19
  • 20. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com  CMS lists various functions that are considered FDRs (and for which health plans are responsible.)  Examples of these functions -- • Sales and marketing; • Utilization management; • Quality improvement; • Applications processing; • Enrollment, disenrollment, membership functions; • Claims administration, processing and coverage adjudication; • Appeals and grievances; • Licensing and credentialing; • Pharmacy benefit management; FDRs 20
  • 21. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com  FDR Examples, continued • Hotline operations; • Customer service; • Bid preparation; • Outbound enrollment verification; • Provider network management; • Coordination with other benefit programs such as Medicaid, state pharmaceutical assistance or other insurance programs; • Entities that generate claims data; and • Health care services. FDRs, continued 21
  • 22. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com CMS Diagram – Part C (MA) 22
  • 23. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com • CMS authority to take enforcement or contract actions against Medicare plan sponsors – Civil Money Penalties (CMP) – Intermediate Sanctions (i.e., suspension of enrollment, marketing, payment) – Termination • Over 100 enforcement / contract actions since 2008 • Responding to sanctions / violations requires submission and implementation of Corrective Action Plans (CAPs): – Identification of Violation – Root Cause Analysis – Beneficiary Impact Analysis – Description and Explanation of Corrective Action – Description of / Explanation of Beneficiary Remediation • CMS issued first sanction related to compliance program violations Part C and Part D Enforcement Actions 23
  • 24. Intermediate Sanctions • CMS imposition of intermediate sanctions on Part D plans that fail to operate in accordance with CMS requirements • Suspension of marketing and enrollment in response to: Plan A (May 28, 2014) • Applied unapproved utilization management practices in formulary • Denial letters lacked adequate rationale or contained inaccurate information • Failure to obtain additional prescriber information to make clinical decisions • Failure to properly oversee delegated entity, and other violations Plan B (Aug. 11, 2014) • Failure of medical director to oversee coverage determination appeals effectively • Misclassified coverage redetermination requests as grievances • Applied unapproved quantity limits in formulary, and other violations Plan C (Jan. 21, 2016) • Failure to properly oversee delegated entities responsible for processing Part C organization determinations, appeals and grievances • Failure of compliance officer to provide updates on results of monitoring, auditing, and compliance failures to senior leadership • Failure to establish formal risk assessment program • Failure to maintain documentation of identified deficiencies and corrective actions taken • Failure to develop and implement an effective system for corrective actions require of first tier entities • Untimely notification to beneficiaries/providers of determinations as part of expedited organization determination and reconsideration requests • Applied unapproved quantity limits in formulary, and other violations
  • 25. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Health Plan/Health System Compliance Programs  CMS allows health plan sponsors or their parent organizations to run the health plan’s compliance program  Where that parent organization is a health system, is that a good idea?  Key differences between health system/health plan compliance obligations • Health system compliance obligations are voluntary (unless the health system is under a CIA)/health plan compliance programs are mandatory • Health system compliance programs are largely administrative/health plan compliance programs are expected to assure operational compliance • Health system compliance programs use different verbiage than health plan compliance programs oFraud and abuse vs. fraud, waste and abuse (FWA)! (Makes a difference during a site visit/survey) • Health system risks are different from health plan risks oCMS Sanctions versus FCA investigations 25
  • 26. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Health Plan/Health System Compliance Programs  Necessary Firewalls? • Consider also firewalls for antitrust purposes in a context in which operational compliance is key and you are responsible for downstream entity (i.e. provider) compliance • Will health system compliance program be monitoring operations of competing providers?  Consider parent compliance program assuming some compliance program functions where efficiencies can be gained (i.e., exclusion checks, etc.) but having separate compliance officer infrastructure. 26
  • 27. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. ebglaw.com Enterprise Risk Management: The Next Step
  • 28. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com What is Enterprise Risk Management?  According to COSO*, it is – • A process, • effected by an entity's board of directors, management, and other personnel, • applied in strategy setting and across the enterprise, • designed to identify potential events that may affect the entity, • and manage risk to be within its risk appetite, • to provide reasonable assurance regarding the achievement of entity objectives *Committee of Sponsoring Organizations of the Treadway Commission 28
  • 29. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com 29 Enterprise Risk Management Structure – Break Down the Silos! Enterprise Risk Management AuditCompliance
  • 30. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com 5 Best Practices for an Effective Enterprise Risk Management Process 1. Establish a comprehensive ERM policy • Incorporate all risk functions including compliance, audit • Avoid silos to optimize all metrics in decision-making 2. Understand and assess risk as it relates to the Company’s immediate and longer term objectives, and consider risk management efforts • Encourage open discussion of “what keeps people awake at night” • Incorporate ERM into the strategic planning process --Sources: the American Institute of CPAs (AICPA), “Top 10 ‘Next’ Practices for Enterprise Risk Management,” http://www.academia.edu/8716339/Top_Ten_Next_Practices_for_Enterprise_Risk_Management_2010_AIC PA_Survey_Results_Table_of_Contents_Top_Ten_Next_Practices_for_Enterprise_Risk_Management; McKinsey & Co., From Compliance to Value Creation: The Journey to Effective Enterprise Risk Management for Insurers 30
  • 31. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com 5 Best Practices for an Effective Enterprise Risk Management Process 3. Create a partnership with between ERM and business • Use ERM to guide the behavior and thought process of decision-makers • Communicate regularly, thoroughly, top to bottom, bottom to top and across the organization 4. Establish the right monitoring processes to make sure risk mitigation activities operate as designed • Regularly track and monitor the risks facing the organization both internally and externally 5. Make ERM a top priority of the Board of Directors and senior management • Promote a risk-oriented culture (soft skills are important) • Make risk part of your story of organizational value (public relations strategy) 31
  • 32. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. ebglaw.com Establishing Enterprise Risk Management Priorities
  • 33. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Establishing Enterprise Risk Priorities: Heat Map 33 Low High High Significance (financial, strategic, reputational, etc.) Likelihood (considering controls and inherent risks)
  • 34. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Greater Connectivity, Higher Risk  Greater interconnection and interdependency among health care entities expand vulnerabilities, which affects any entity connected with the health plan (vendors, suppliers, partners, customers)  Lack of board room or senior management expertise often creates challenges when overseeing risks and risk management efforts 34
  • 35. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Interconnection & Integration 35 Insurance Patients Physicians Health Plans Integrated Delivery PhysiciansHome Health PatientsMedical Devices Labs Insurance
  • 36. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Management’s ERM Process Regarding Strategic Partnerships and Alliances 36  Definition of a strategic partner/alliance • Company enters into a relationship with a third party to provide a unique service or technology that is critical to the company’s strategy, operations, and success • Generally a longer term relationship • Longer, more strategic, and greater impact than a normal vendor contract  All health plans have a strategic partner or alliance • FDRs are strategic partners • Example: PBMs
  • 37. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Potential Risks Regarding Strategic Partnerships and Alliances 37  Partnering for critical services leaves the Company with less control • Potential impact on sales, operations, customer/member satisfaction, profitability, and compliance  Failure of partner to perform as expected would negatively impact consultants/brokers/employers/employees/government relationships  Company likely would be responsible for partner’s activities, even outside the MA context  Potential changes can occur at the partner • Change in ownership or senior management • Shift in strategy, products, or customer base • Reputational issues • Financial issues
  • 38. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com A Few Caveats About Using Heat Maps for Compliance Purposes  Everyone knows compliance is a high risk area in terms of significance  BUT…No one ever thinks they are at high risk (i.e., likelihood) for a sanction!  Why?  EDI (Everybody’s Doing It) • People assume everyone else’s reported struggles with compliance concerns means they are not outliers • But there is always a “first” when it comes to enforcement actions • Examples – 2014 was first CMS Sanction; 2016 was first CMS Sanction with Compliance-specific  People assume that their policies and procedures, or the Compliance Program generally, or their choice of a qualified, reputable FDR, are sufficient to mitigate identified high risk areas. 38
  • 39. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Heat Map: Enterprise Risk of Sanction (from FDR Relationships) 39 Low High High Significance (financial, strategic, reputational, etc.) Likelihood (considering controls and inherent risks)
  • 40. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Health Plan Areas of Vulnerability  Items with direct beneficiary impact, including: • Denial decisions • Claims payment • Grievances and appeals  Marketing and Enrollment Practices – particularly agent misrepresentation  Inappropriate Risk Adjustment and Misclassifications  Defective Data or Bid Submissions (both incomplete and inaccurate submissions)  Direct and Indirect Remuneration Reporting and Characterization (drug costs)  Relationships with Providers and Downstream Contractors 40
  • 41. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com  Underutilization  Financial incentives built into capitated rates  Withhold or risk-sharing arrangements  Discouraging treatment is prohibited  Disallowing medically necessary covered services  Doing business with excluded individuals  Failure to pay providers  Retaining overpayments collected from providers  Plans may be held responsible for the actions of their downstream contractors Health Plan Areas of Vulnerability (continued) Relationships with Providers and Downstream Contractors 41
  • 42. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. ebglaw.com Preparing Your Health Plan to Stay Ahead of Enterprise Risks
  • 43. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Health Plans and Other Health Care Organizations  Adopt a comprehensive ERM policy at the management and board level  Educate board management and employees frequently  Consider adopting the 5 Best Practices for ERM  Consider CMS relationship (Medicare/Medicaid) as one high risk that deserves resources for risk management mitigation efforts  Consider reviewing Strategic Partnerships and Alliances as one high risk that deserves resources for risk management mitigation efforts 43
  • 44. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com  Provide time to build the Board’s Federal Health Care Program/CMS Literacy, as well as ERM • Consider having a special committee or subcommittee address specific enforcement actions/areas of vulnerability  Provide regular reports to Board • Determine risk and risk thresholds to be reported • Evaluate risk management efforts Addressing Risk in the Board Room Putting Key Risks on the Board Agenda 44
  • 45. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com  Formulate strategic response plans  Consider the role of Strategic Partners and Alliances in risk management  Create strategies that would confront the company’s worst possible scenarios and protect its highest value targets • From the perspective of the organization and external actors  SEC Disclosure Considerations, if any or Bond Debt Considerations • Standard of materiality  HHS OIG Compliance Considerations Addressing Key Risks in the Board Room Management Responsibilities 45
  • 46. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Mitigating Risk Before a Sanction Occurs  Proper Policies and Procedures • Stay current on CMS priorities • Refresh training programs  Mock Audits  Contracts with Downstream Vendors (PBMs, etc.) • Plan is responsible for actions of downstream vendors • Include rights for downstream audits and CAPs 46
  • 47. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Mitigating Risk Before a Sanction Occurs  Appropriate Self-Monitoring • Regular internal audits • Compliance Auditing and Monitoring (Effectiveness Reviews)  Public Relations Firm • Ready to activate for addressing press and member concerns  Internal Response Plan • Early and often CEO communication with CMS • Special Committee of the Board • Build Board expertise 47
  • 48. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com  Upfront Risk Mitigation Steps • Conduct a thorough initial due diligence of the operational capabilities and financial conditions of the strategic partner • Understand the strategy of the partner to make sure there is a good strategic and cultural fit for both partners and that they share a common goal • Draft a strong contract that provides protection regarding governance, performance expectations and standards, changes of ownership, dispute resolution, exclusivity, potential indemnification, and other key issues  Ongoing Risk Mitigation Steps • Conduct regular reviews to ensure compliance and financial stability of partner • Consider frequent on-site visits • Build and maintain strong, mutually beneficial relationships Mitigating the Probability or Impact of the Risks Associated with Strategic Partnerships and Alliances 48
  • 49. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com  The Board of Directors engages in meaningful effort to review the adequacy of existing compliance systems and functions  The Compliance Officer reports periodically directly to the Board on activities and status of compliance program, including issues investigated, identified and resolved by compliance program • Minutes are kept with sufficient detail to enable an auditor to see follow-through • Executive Sessions with the Board?  The Board of Directors receives compliance training  The Board of Directors reviews and approves compliance training  The Board of Directors reviews and approves new and updated policies • A resolution is adopted by the Board approving policies  The Board of Directors oversees that management consistently reviews and audits risk areas, as well as develops, implements, and monitors corrective action plans Mitigating Compliance Risks – A Checklist for the Board 49
  • 50. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. ebglaw.com Appendix – Key Vulnerabilities for Medicare Advantage/Medicaid Health Plans
  • 51. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Marketing and Enrollment Practices  Marketing practices of Medicaid and Medicare Managed Care Organizations face increased scrutiny  Concerns addressed in Medicare Marketing Guidelines include: • Language and cultural competency • Door-to-door solicitation • In-home marketing appointments • Cross-selling of non-healthcare related products • Offering gifts or payments, including meals • White coat / provider based marketing 51
  • 52. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Marketing and Enrollment Practices  Enrollment and disenrollment practices  Managed Care Organization may not discriminate based on: • Race, ethnicity, religion, gender, sexual orientation, health status, geographic location, national origin, mental or physical disability, claims experience, medical history, genetic information, or evidence of insurability  Plans are required to refrain from: • Marketing only to healthy individuals (“cherry picking”) • Avoiding individuals with a high risk for costly or prolonged treatment needs (“lemon dropping”)
  • 53. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Marketing and Enrollment Practices  Amerigroup Case - United States, ex rel. Tyson v. Amerigroup Illinois, Inc. (N.D. Ill) • Jury awarded -- $334 million judgment • Settlement -- $225 million plus a corporate integrity agreement • Allegations that Amerigroup violated the FCA by systematically avoiding enrolling certain patient groups in its Illinois Medicaid HMO  Theories of the case included: • Fraudulent inducement in misrepresenting to Illinois Medicaid • Submission of certifications of compliance that implied non-discrimination • Receipt of inflated capitation payments in violation of state and federal False Claims Act provisions, based on false promises not to discriminate
  • 54. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Inappropriate Risk Adjustment and Misclassifications  Medicare Modernization Act of 2003 • Hierarchical Condition Category Payment System o Payments made to managed care plans based on Risk Adjustments o Risk Adjustment Factors o Plans with a healthier membership reimbursed less than “sick” membership  Potential liability under False Claims Act  45 Day CMS Payment Notices- CMS proposed that codes derived from in-home risk assessments would not be accepted, never finalized proposals.
  • 55. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Inappropriate Risk Adjustment and Misclassifications Recent Settlements  United States v. Walter Janke, MD, Lalita Janke and Medical Resources, LLC (2012) • Government sued under FCA for submission of upcoded diagnoses codes to increase risk adjustment scores • Settled with DOJ = $22.6 million  United States and State of California ex rel. Swoben v. SCAN Health Plan (2012) • Relator alleged ScanHealth inflated risk adjustment scores • Settled with DOJ = $3.82 million
  • 56. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Inappropriate Risk Adjustment and Misclassifications United States ex rel. Olivia Graves v. Plaza Medical Group, Corp, Humana, Inc., Michael Cavanaugh, and Spencer Angel • Allegations: Physician manipulated diagnostic codes to inflate Medicare Part C capitation payments and that Humana was aware or should have been aware of a significant increase in patients diagnosed with diabetes/renal or peripheral circulatory problems. United States of America ex rel. Jose R. Valdez v. Aveta, Inc.; MMM Healthcare, Inc.; PMC Medicare Choice, Inc.; MSO of Puerto Rico, Inc.; MMM Holdings, Inc. • Allegations: Diagnosis codes that were unsubstantiated by medical records or by medical conditions of the Medicare beneficiaries. Internal audit showed that over 2/3 of patient risks scores were unsupported by medical documentation.
  • 57. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Defective Data or Bid Submissions Plans are responsible for complete and accurate bids to CMS.  Incomplete Submissions – bids will not be accepted by CMS if any required component is not submitted by deadline  Inaccurate Submissions: • “Clearly inaccurate” call into question sponsor’s ability to fully comply with program requirements • Sponsors submitting inaccurate Part D bids may receive a corrective action plan or may have their bids denied • CMS examples of “clearly inaccurate” information: oA bid for an enhanced plan but not a basic plan oA bid for a non-defined standard plan that does not meet Part D benefit parameters oAn incorrect crosswalk between the plan benefit package and formulary
  • 58. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Defective Data or Bid Submissions Inaccurate bids to CMS may trigger fraud enforcement  All information that plan sponsors submit to CMS in connection with a bid may provide the basis for a false claim action • Plan sponsors “must certify (based on best knowledge, information, and belief) that the information in its bid is accurate, complete, and truthful and fully conforms with [submission requirements].”  CMS audits at least one third of annual bid submissions to protect against improper submissions
  • 59. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Defective Data or Bid Submissions  Amerihealth Mercy Health Plan paid over $2 million to Kentucky Medicaid for falsely reporting its Health Effectiveness Data Set (HEDIS) score for Cervical Cancer Screenings in order to obtain bonus money from the Department of Medicaid Services.  CareSource paid $26 million for allegedly submitting false data that it provided screening, assessment, and case management services to retain incentive portion of capitation payments.  PacifiCare settlement for $87 million for allegedly including unallowable items in calculation of ACR, including lobbying and entertainment costs, costs of related organizations.
  • 60. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Medical Loss Ratios  Medical Loss Ratio rules require that insurers spend at least 85% of large group premium revenue and 80% of small group and individual policy premium revenue on: • Medical care • Healthcare quality improvement activities  In 2012, Wellcare Health Plans agreed to pay $137.5 million to the federal government and nine states to resolve four lawsuits alleging FCA violations and enter into a five-year Corporate Integrity Agreement. • Some State Medicaid programs had MLR thresholds, e.g., Florida established minimum MLR requirements for Medicaid premiums for behavioral health services
  • 61. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Relationships with Providers and Downstream Contractors Case Examples  Keystone Mercy Health Plan – settlement for $5 million for allegedly keeping overpayments it collected from providers instead of refunding the State of Kentucky  IntraCorp – settlement with 6 States and the Federal Government for $3.15 million for alleged failure to provide adequate written utilization review criteria to providers, as well as not providing adequate quality and training assurance programs and other utilization management inadequacies  Tower Health – criminal charges stemming from allegedly siphoning funds to affiliated entities instead of paying providers, falsification of financial data.
  • 62. © 2015 Epstein Becker & Green, P.C. | All Rights Reserved. | ebglaw.com Presented by Carrie Valiant Senior Member of the Firm, Epstein Becker Green cvaliant@ebglaw.com 202-861-1857 62