Fraud, Waste, and Abuse Panel

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1 Fraud, Waste, and Abuse Panel HCCA Managed Care Compliance Conference February 9, 2014 Today s Panel Discussion Summary of FWA requirements as part of an effective compliance program Jose Tabuena Current trends and applicable takeaways in today s FWA environment Adam Rattner Applying culture change principles and a proactive approach to FWA prevention through Medicaid contract compliance Jack Bevilacqua 1

2 Summary of FWA Requirements as part of a Compliance Program Jose Tabuena, Concentra Humana Inc. Know Your History Office of Inspector General, US Department of Health and Human Services Compliance Guidance Compliance Program Guidance for Medicare+Choice Organizations (1999) Link: Centers for Medicare and Medicaid Services Medicare Prescription Drug, Improvement, and Modernization Act (2003) o Guidance for Part D (Chapter 9) included the FWA component as part of a plan sponsors overall compliance plan program requirements (2006) o FWA program could be separate and in addition to compliance program, or integrated Medicare Managed Care Manual (Chapter 21, Pub ) and Prescription Drug Benefit Manual (Chapter 9, Pub ): These guidelines are identical and allow organizations offering both Medicare Advantage (MA) and Prescription Drug Plans (PDP) to reference one document for guidance (Revised ) Link: Guidance/Guidance/Manuals/Downloads/mc86c21.pdf 2

3 Chapter 21 and 9 Compliance Program Guidelines Each sponsor must implement an effective compliance program that meets the regulatory requirements set forth in Chapter 42, Parts 422 and 423 of the Code of Federal Regulations. Section in Guidelines Element of an Effective Compliance Program 50.1 Written Policies, Procedures, and Standards of Conduct 50.2 Compliance Officer, Compliance Committee, and High Level Oversight 50.3 Effective Training and Education ( FWA Training) 50.4 Effective Lines of Communication 50.5 Well Publicized Disciplinary Guidelines Effective System for Routine Monitoring, Auditing and Identification of Compliance Risks ( Use of Data Analysis for FWA Prevention and Detection; Special Investigation Units (SIUs) Procedures and System for Prompt Response to Compliance Issues ( Procedures for Self-Reporting Potential FWA and Significant Non-Compliance; Responding to CMS-Issued Fraud Alerts) Definitions In the Compliance Program Guidelines FWA means fraud, waste and abuse. Fraud Is knowingly and willfully executing or attempting to execute, a scheme or artifice to defraud any health care benefit program or to obtain (by means of false or fraudulent pretenses, representations, or promises) any of the money or property owned by, or under the custody or control of, any health care benefit program. 18 U.S.C Fraud is a deliberate misrepresentation or deception intended to result in financial gain. It is a criminal act. Abuse Includes actions that may, directly or indirectly, result in: unnecessary costs to the Medicare Program, improper payment, payment for services that fail to meet professionally recognized standards of care, or services that are medically unnecessary. Abuse involves payment for items or services where there is no legal entitlement to that payment and the provider has not knowingly and/or intentionally misrepresented facts to obtain payment. Abuse includes actions similar to fraud but not proven to be criminal. 3

4 FWA Definitions, continued FWA means fraud, waste and abuse. Fraud versus Abuse Abuse cannot be differentiated categorically from fraud, because the distinction between fraud and abuse depends on specific facts and circumstances, intent and prior knowledge, and available evidence, among other factors. Waste Is the overutilization of services, or other practices that, directly or indirectly, result in unnecessary costs to the Medicare program. Waste is generally not considered to be caused by criminally negligent actions but rather the misuse of resources. Chapter 21 and 9 Guidelines Evolving Thoughts Specifically, the chapter provides recommendations and requirements for Sponsors to implement a program to control fraud, waste, and abuse as part of an effective Part D compliance program. It is worth noting that for many Sponsors, traditional fraud, waste, and abuse programs have been aimed at the conduct of third parties... whereas their compliance programs typically encompass the organization s efforts to monitor itself and its subcontractors with respect to contract regulations and compliance with applicable laws and regulations. CMS believes that, under this requirement, Sponsors must have policies in place to identify and address fraud, waste and abuse at both the Sponsor and third-party levels... 4

5 Two Perspectives Compliance and Fraud control programs should not be looked at in a silo Compliance Risk of Non-compliance and Misconduct (including fraud) by the organization. For most compliance program activities, the audience is primarily internal and draws more on education and protecting the organization from legal actions brought by others. Fraud Control Risk of External Fraud against the Organization For most antifraud activities, the target audience is primarily external and draws heavily from data mining, investigations, law enforcement, and legal actions initiated by the organization. Compliance and FWA leverage many of the same principles Ethics and Compliance Program Compliance Policies and Procedures Compliance & Ethics Training Code of Conduct Policies Whistleblower Helpline Training & Education Hiring and Promotion Standards Antifraud Program & Controls Antifraud Policies and Procedures Fraud Awareness Training Internal Misconduct Compliance Risk Assessment To Detect Non-compliance Regulatory Requirements Investigations Oversight BOD & AC Enterprise Risk Assessments Incentives & Discipline Auditing and Monitoring Evaluate Effectiveness Technology & Metrics External Fraud Fraud Risk Assessment To Detect Criminal Conduct Fraud Detection Data Analysis 5

6 Compliance and Antifraud Programs leverage many of the same technologies For many companies, technology to support the Compliance and Antifraud Programs can be implemented primarily using software solutions with existing footprints in their application architectures Antifraud Program Activity Control Environment Risk Assessment Control Activities Information and Communication Monitor Functionality Whistleblower/compliance hotline; employee training and tracking; supporting and documenting background checks; data analytics; electronic data recovery and preservation. Identifying and documenting compliance and fraud risks and the related controls; identifying and documenting related policies, procedures and system protocols; template test plans for relevant controls, issue documentation and tracking; documenting results of control testing; reporting. System and process related security and controls; manage user access and segregation of duties; automated monitoring tools. E-Learning system to managing content and provide online training; documentation on who has completed training and when. Monitoring changes in the parameters in control configuration tables; monitoring who has accessed transactions, financial system modules, and content; analyzing transactions for anomalies; journal entry testing; monitoring manual processes;. Compliance versus FWA Risk Compliance and Fraud control programs should not be looked at in a silo Do fraud specialists SIU and internal auditors have a common interest with compliance and ethics professionals? Could compliance officers enhance compliance by working more closely with their organization s antifraud professionals? Is there an effective way to integrate the required infrastructures? 6

7 A look at Antifraud Program Controls The fraud control strategy includes 4 key paradigms 1. Reactive strategies, proactive scanning, and prevention within functional scopes of responsibilities 2. Utilizing a range of tools and methods, including investigations, inspections, audit, data mining, and policy and systems development 3. Creative use of data-analysis and pattern recognition systems; a serious appetite for integrating data from disparate sources to provide the opportunity to conduct more sophisticated analyses and searches 4. Covering a a considerable range of risks and developing over time the program s own sense of the relevant risk-profile The Fraud Risk Assessment A fraud risk assessment is crucial part of an entity s broader risk assessment process Considers the ways that fraud and misconduct can occur Is systematic and recurring Considers possible internal and external fraud schemes and scenarios Assesses risk at entity-wide, significant business unit and significant account levels Evaluates likelihood, significance and pervasiveness of each risk Is performed with the involvement of appropriate personnel Considers management override Is dynamic and should be updated when new or unique circumstances arise (e.g., changed operating and regulatory environments) at least annually 7

8 Where money flows, fraud is likely to follow Identify Possible Fraud Schemes Determine specific fraud schemes without consideration of existing controls A scheme is the mechanism, scenario, or sequence of actions by which; The financial statements may be improperly manipulated or misstated; Assets may be misappropriated; Improper or unauthorized expenditures may be made; Self-dealings may occur; and Laws and regulations may be violated. One or more related fraud schemes may exist for each fraud risk, consider the following; Past fraud within the organization, actual and alleged The industry in which the organization operates The geographies in which the organization operates 8

9 Compliance and FWA Risk Examples of Areas of Exposure for Plan Sponsors Enrollment Accuracy LIS, Duals, late penalty, effective dates Billing Accuracy Premiums (direct & SSA), refunds, cost sharing Bids and Reconciliation cost allocations, assumptions Formulary Development/Management and Beneficiary Notifications COB Data Collection TrOOP Accumulation Cherry picking of healthy patients Inflation of expenses Data that misrepresents the medical condition of patients and treatments received; manipulating Risk Adjustment payment system Rebates and Arrangements with pharmacies and manufacturers Implementing Relevant Internal Controls Plans should begin to think about how to move their Compliance/FWA programs from reactionary to proactive The value proposition of this approach is to provide plans with a real-time, Sarbanes-Oxley like control design, testing and remediation. Automated and independent of a Mock Audit and other internal monitoring and auditing procedures. Multi-phased approach for developing and implementing internal controls for MA plans, MA-PDs and PDPs. Based on code elements defined in the respective manuals, and regulatory and compliance guidelines. The objective is to develop and implement a robust set of controls that prevent compliance compromising situations from occurring in the first place, or detect them on a real time basis. 9

10 What are Internal Controls? In accounting and auditing, internal control is defined as a process affected by an organization's structure, work and authority flows, people and management information systems, designed to help the organization accomplish specific goals or objectives. Risks: Uncertain events that could adversely impact compliance with the MA and PDP Requirements. Control Objectives: Management's goals which, if achieved, reduce the identified risks to an acceptable level. Control Activities: Processes or sub-processes that provide reasonable assurance regarding the reliability and integrity of the control objective. Fraud and Internal Control Internal control plays an important role in the prevention and detection of fraud. Under Sarbanes-Oxley, companies are required to perform a fraud risk assessment and assess related controls. This involves identifying scenarios in which theft or loss could occur and determining if existing control procedures effectively manage the risk to an acceptable level. The risk that senior management might override important financial controls to manipulate financial reporting is a key area of focus in a fraud risk assessment. The AICPA, IIA, and ACFE sponsored a guide that includes a framework for helping organizations manage their fraud risk. Managing the Business Risk of Fraud: A Practical Guide (2008) Managing_the_Business_Risk_of_Fraud.pdf 10

11 Types of Control Activities Preventive control activities: Designed to avert problems rather than identify them Examples include cost report model, access restrictions, etc. Detective control activities: Meant to identify errors or irregularities after the fact Examples include reviews, reconciliations, and analyses A good internal control structure includes an appropriate blend of preventive and detective controls. Types of Control Activities (continued) Manual control activities: Carried out by people Examples include management approvals, review of reports, reconciliations performed by hand, etc. Automated control activities: Are configured or programmed into systems and are executed by a system automatically Examples include access restrictions, edit and validation checks, etc. Automated control activities are more consistent than manual control activities, however they are reliable only if the related general computer controls are effective (e.g., security). 11

12 What are control activities? Know Available Resources Office of Inspector General, US Department of Health and Human Services Managed Care Web Page: Home>Fraud>Enforcement>CMP>Managed Care Office of Evaluation and Inspections Reports Home>Reports & Publications>Office of Evaluations and Inspections>Reports Medicare Advantage Organizations Identification of Potential Fraud and Abuse ( ) Link: Special Fraud Alerts Home>Compliance>Special Fraud Alerts Link: Corporate Integrity Agreements (and corresponding press coverage) Home>Compliance>Corporate Integrity Agreements Link: 12

13 The Current State and Recent Trends in FWA BY: Adam Rattner, Esq. The views herein are solely of the presenter and do not represent those of any company or person other than the presenter. 25 The Current Estimated Cost to the System of FWA The US Department of health and Human Services Office of the Inspector General ( HHS-OIG ) conservatively estimates that $100 billion is lost to healthcare fraud each year ($273 million per day)

14 FWA DETECTION, PREVETION AND PROSECUTION IS CURRENTLY ON THE RISE: Government agencies have formed partnerships to fight fraud and abuse, as well as to protect taxpayer funds, and maintain health care costs and quality of care. The Center For Medicaid and Medicare (CMS) which administers the Medicare and Medicaid programs partners with the following entities to prevent and detect fraud and abuse: Program Safeguard Contractors (P-S-Cs)/Zone Program Integrity Contractors (Z- PICs), Medicare Drug Integrity Contractors (MEDICs), State and Federal law enforcement agencies, Medicare beneficiaries and caregivers, Senior Medicare Patrol (S-M-P) program, Physicians, suppliers, and other providers, Medicare Carriers, Fiscal Intermediaries (F-Is), and Medicare Administrative Contractors (MACs) who pay claims and enroll providers and suppliers; Recovery Audit Program Recovery Auditors; and Comprehensive Error Rate Testing (CERT) Contractors. 27 The Battle Royale: The current fight against FWA The Center for Program Integrity (CPI), within CMS, promotes the integrity of Medicare by: conducting audits and policy reviews; identifying and monitoring program vulnerabilities; and providing assistance to states. The OIG primarily audits, investigations, inspections, and other functions. The Inspector General may prohibit individuals and entities who have engaged in fraud or abuse from participating in Medicare, Medicaid, and other Federal health care programs. The Inspector General may also impose CMPs for certain misconduct related to Federal health care programs. The Department of Justice and HHS established Health Care Fraud Prevention and Enforcement Action Team (HEAT) to strengthen existing programs to combat Medicare fraud while investing in new resources and technology to prevent fraud and abuse. Excluded Parties List System (E-P-L-S). This list includes information on entities debarred, suspended, or proposed for debarment. The list also includes those entities that have been excluded, or disqualified from receiving Federal contracts, certain subcontracts, and certain types of Federal assistance and benefits

15 Current Recommended guidelines to Prevent FWA Monthly checks for excluded individuals among employees and first tier, downstream, and related entities Processes to identify, deny, prevent payment of claims from excluded providers at point of sale Requires disclosure by employees and first tier, downstream or related entities of new exclusions Establish SIU unit or perform SIU functions through compliance Many state and Federal Contracts make the detection and prevention of FWA (through SIU, Exclusion checks, and others) a mandatory contractual requirement. 29 False Claims Act Bolstered by PPACA Civil False Claims Act Prohibits knowingly presenting a false claim or knowingly making a false record or statement material to a false claim Knowingly includes acting in reckless disregard or deliberate ignorance of the truth or falsity of the information Penalties include treble damages and civil penalties Qui tam provisions allow individuals (e.g., employees, contractors, providers) to sue and share in ultimate recovery Overpayment Amendments (FERA & PPACA) FERA expanded FCA liability by including knowing retention of overpayments (same definition of knowledge as above) PPACA requires that overpayments be reported and repaid within 60 days after identification 30 15

16 Civil and Administrative Enforcement The OIG reported that it obtained expected recoveries of $3.8 billion (including both audit receivables and investigative receivables) in the first half of FY During the same time period, over 1,500 individuals were excluded from participation in the federal health care programs and 240 civil actions were undertaken by OIG, including false claims and unjust enrichment cases, civil monetary penalties settlement and administrative recoveries related to provider selfdisclosure matters. 31 FWA Civil and Administrative Enforcements 2013 FCA violations in 2013 $350 million settlement with generic drug manufacturer Ranbaxy Laboratories Limited for False Claims Act violations related to the manufacture and distribution of adulterated drugs at its facilities in India. The government intervened in the whistleblower suit alleging that the strength, purity or quality of several drugs manufactured at two facilities differed from the drug s specifications or that the drugs were not manufactured according to the FDA-approved formulation. Kan-Di-Ki, doing business as Diagnostic Laboratories and Radiology, agreed to pay $17.5 million to resolve allegations it submitted false claims to Medicare and Medi-Cal by engaging in an illegal kickback scheme known as a swapping arrangement by charging skilled nursing facilities below-cost rates for Medicare Part A business, in exchange for the facilities provision of Medicare Part B and Medi-Cal business. Omnicare announced an expected $120 million settlement with the DOJ for a swapping arrangement involving discounts for Part A drugs provided to nursing homes in exchange for the nursing homes Part D referrals. Stark Law violations in United States ex rel. Baklid-Kunz v. Halifax Hospital Medical Center, et al.,-a hospital violated the Stark Law by paying oncology physicians illegal productivity bonuses. U.S. ex rel. Drakefordv. Tuomey Healthcare System Inc. -$237 million in damages and fines in a whistleblower case after a jury determined that Tuomey had violated the Stark Law because the compensation paid to several specialty physicians under part-time employment agreements varied with or took into account the volume or value of referrals to the hospital

17 FWA Criminal Prosecutions 2013 Nov. 2013, DOJ announced a significant settlement with Johnson & Johnson 2.2 billion will be paid for criminal and civil liability arising from allegations of off-label marketing and AKS allegations. The criminal fines and forfeiture alone totaled $485 million. American Therapeutic Corporation and the American Sleep Institute submitted false and fraudulent claims to Medicare for services that were medically unnecessary, were not eligible for Medicare reimbursement or were never provided. -24 individuals charged and 15 convictions for a combined 183 years in prison to date. -The 15 defendants also were ordered to pay $87 million in restitution and $37,000 in fines. 33 FWA development-hhs declares QHP s not within Scope of AKS It is anticipated that enforcement will remain active in 2014, however, industry opinion suggests the recent legal interpretation by the Obama administration related to QHPs could weaken government efforts. At issue is whether QHPs available on the health insurance exchanges, to become effective on Jan. 1, 2014, are considered federal health care programs and thus subject to the AKS, which prohibits the offer, payment, solicitation or receipt of remuneration intended to influence the referral of services to be paid for by a federal health care program. The government still has broad authority to pursue fraud and abuse involving QHPs under program integrity rules, civil money penalties, the False Claims Act and a variety of federal criminal laws. QHP s are still a Health Care Benefit, and thus subject to Federal Criminal Law and prosecution for violation of federal criminal healthcare laws

18 The rising shift to Managed Care More and More, States have attempted to contain costs of Medicaid programs by shifting Medicaid payments for health care services for recipients from fee for service based cost reimbursement to capitated rates paid to managed care plans FWA May include both fraud by the MCO and fraud against the MCO by providers 35 Managed Care Plan Fraud Contract procurement fraud (provider credentials, financial solvency, inadequate network, bid-rigging) Marketing and enrollment fraud (slamming, enrolling ineligible or non-existent recipients, cherry-picking, kickbacks, lemon-dropping) Underutilization (delays, denials, unreasonable prior auth requirements, gag orders to providers) Claims submission and billing fraud (misrepresent MLR, dual eligible scams, cost-shifting to carve-outs, misrepresent kickeligible services or incentivized services, encounter data fraud) 36 18

19 Recent findings/trends in FWA Hospital Post acute Discharges and Transfers. Medicare overpaid millions to hospitals for claims subject to the post acute care transfer policy reduced rate. Hospital Claims for Mechanical Ventilation. Medicare overpaid millions to hospitals that used the incorrect procedure code for mechanical ventilation. Hospital Claims for Canceled Elective Surgeries. Medicare overpaid millions to hospitals for canceled elective surgeries. Hospital Inpatient and Outpatient Claims in Risk Areas. Hospitals that appear to be at risk of submitting significant noncompliant claims to Medicare are subject to OIG review; risk areas are identified through data mining and analysis. Outpatient Therapy Services An outpatient therapy supplier improperly billed most of its claims to Medicare; the supplier did not have a thorough understanding of Medicare s requirements and did not have adequate policies and procedures in place to ensure correct billing. 37 Recent findings/trends in FWA Hospitals Early Discharges to Hospice Care. Medicare pays hospitals more for early discharges to hospice care than it pays for early discharges to certain other care settings; Critical Access Hospitals (CAHs). Medicare and its beneficiaries pay more for care in CAH-certified hospitals, but most CAHs would not meet the location requirements if required to re-enroll in Medicare. Laboratory Tests. Medicare paid more for lab tests than did the State Medicaid programs and Federal Employee Health Benefit (FEHB) plans that the OIG reviewed; better aligning payments with Medicaid and FEHB could yield substantial savings. Medical Equipment/Supplies Continuous Positive Airway Pressure (CPAP) Therapy. Medicare s replacement schedule for CPAP supplies has remained largely the same for the past 20 years and may not align with current payers and professional recommendations. Part B Prescription Drugs. Medicare could recoup billions on Part B drug costs if pharmaceutical manufacturers were required to pay rebates as they do for Medicaid drugs. Dialysis Anemia Management Drugs. Utilization of anemia management drugs in dialysis treatments in 2011 was generally significantly less than the utilization reflected in the base rate calculation; adjustments could yield savings for Medicare. Claims Processing G Modifiers. Medicare contractors fail to consider billing codes that flag claims as being unallowable for payment; practice and procedure adjustments are needed

20 New FWA concerns: MLR Requirements and FWA MRI Scan Center, LLC v. Nat l Imaging Assocs., Inc. Filed early Alleges manipulation of Explanation of Benefits and Remittance Advices to avoid paying MLR rebates under ACA. 39 Final Thoughts on FWA Managed Care World-More and More moving towards the Prevent upfront rather than the pay and chasethis requires big data and information sharing-both of which are becoming huge in the fight against Fraud Waste and Abuse. Private-Public Partnerships are on the rise. Fraud, Waste and Abuse: much like the prevention and detection is ever evolving. The target moves often. The government is relying more and more on healthcare providers and payers to help with the detection and prevention of fraud, through regulations or contractual obligations

21 FWA PANEL: CULTURE CHANGE AND A PROACTIVE APPROACH TO FWA PREVENTION THROUGH MEDICAID CONTRACT COMPLIANCE Jack Bevilacqua Senior Compliance Oversight Specialist WellCare Health Plans, Inc. FRAUD, WASTE, AND ABUSE GOALS OF OVERSIGHT Goals of Compliance Oversight Department as it relates to FWA: Proactive identification of areas particularly susceptible via risk assessment Promotion of self-reported non-compliance by business units Culture change Increased transparency of business operations to compliance Frequent learning opportunities Consistent application of compliance via centralized approach 42 21

22 FRAUD, WASTE, AND ABUSE PREVENTION PROCESS Attestation Process Identification of obligations in contracts and regulations Identification of the people in business operations who are specifically responsible for those obligations. Obtain accountability of the business units by asking them to attest to the compliance or non-compliance of their obligations Benefit Documented accountability that results in management accountability in processes and results. 43 FRAUD, WASTE, AND ABUSE PREVENTION BY COLLABORATION Self-reported non-compliance (Collaboration process) Set face to face meeting with business owner that self reported noncompliance to help them work through their issues of non-compliance. Benefits Branded as collaboration to assist in culture change; end goal would be for operations personnel to proactively identify and come to compliance unprovoked. Creation of metrics to show consistent areas of risk; mitigation of risk by resolving issues prior to them becoming major areas of concern. Opportunity for compliance to learn business operations; business operations to learn compliance

23 FRAUD, WASTE, AND ABUSE PREVENTION BY VALIDATION Self-reported compliance (Validation process) Perform desk review based upon risk level of obligations a combination of impact, likelihood, and historical non-compliance, most notably external findings more so than internal findings of non-compliance. Face to face meetings with management personnel from business operations. Policies and Procedures, Process documents, Internal Controls/Governance, and Data Set/business metrics that prove compliance. Benefits Increased transparency of business operations to compliance Request of data/business operations metrics more robust compliance indicators. Opportunities for compliance to learn business; business to learn compliance with increased knowledge comes greater understanding of each other s roles and mutual respect. 45 FRAUD, WASTE AND ABUSE CULTURE CHANGE Approach to culture change: Walking the Talk Basis for change to be more collaborative, so don t initiate behind a computer screen. Go out and meet business owners face to face to explain the process and new direction. Requested feedback, incorporated feedback into approach. Elicited overt support from Chief Compliance Officer. Run process through friends of compliance within the business units or people you have already connected with. This will enable you to attain some wins. Give positive feedback to the business units and to the managers of those who exhibited behaviors that you want to reinforce

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