Fraud, Waste and Abuse CareMore s Program for Prevention, Detection and Response C A R E M O R E M E D I C A L E N T E R P R I S E S

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1 Fraud, Waste and Abuse CareMore s Program for Prevention, Detection and Response 1 C A R E M O R E M E D I C A L E N T E R P R I S E S

2 Key Program Objectives 2 This course will cover FWA in the Medicare Advantage and Prescription Drug Benefit program, including information on: the increased scrutiny of the government on Medicare managed care fraud and abuse; specific areas of high risk for non-compliance in Medicare Advantage plan and government and regulatory perspective on those areas; kickbacks, referrals, inducements, and laws governing these areas of concern including: the Anti-Kickback Act, Stark Law, and the Beneficiary Inducement Statute; and CareMore s compliance program design, including mechanisms for reporting suspected FWA or non-compliance. Prevention, Detection, Response CareMore s approach to FWA and Compliance risk management encompasses controls that have three objectives: Prevent. Reduce the risk of fraud and misconduct from occurring. Detect. Discover fraud and misconduct when it occurs. Respond. Take corrective action and remedy the harm caused by fraud, waste, abuse or misconduct. Corrective action must also include implementing procedures to prevent future recurrences. Program Design CareMore has developed a comprehensive program to: Understand all of the various control frameworks and criteria that apply to CareMore and the CMS regulatory environment; Categorize risk assessments, codes of conduct, and whistleblower mechanisms into corporate objectives; and Create a broad ranging program that manages and integrates FWA prevention, detection, and response efforts.

3 Government Focus 3 Healthcare fraud enforcement is a top priority for the current administration. On May 20, 2009, the President signed the Fraud Enforcement and Recovery Act (FERA) into law. FERA introduced significant changes to the False Claims Act and provided hundreds of millions of dollars for enforcement. Also on May 20, 2009, the United States Attorney General and the Health and Human Services Secretary announced a new and aggressive interagency task force called the Health Care Fraud Prevention and Enforcement Action Team (HEAT) to combat Medicare and Medicaid fraud. Health plans are already seeing a number of HEAT initiatives that directly impact their operations. The HEAT task force will increase program integrity activities to monitor and ensure Medicare health plans compliance and enforcement. On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act (the Affordable Care Act), which contains numerous provisions intended to allow CMS to take several new and aggressive steps to combat waste, fraud, and abuse in the health care system. The Affordable Care Act provided CMS with $350 million in new resources to boost anti-fraud activities. In addition, the law gave CMS new flexibility in how anti-fraud resources may be used.

4 Relevant Laws 4 The False Claims Act The Fraud Enforcement and Recovery Act (FERA) The Anti-Kickback Statute The Beneficiary Inducement Statute The Self-Referral Prohibition Statute (Stark Law) The Red Flag Rule (Identity Theft Protection) The Health Insurance Portability and Accountability Act (HIPAA) The Patient Protection and Affordable Care Act (the Affordable Care Act)

5 Relevant Examples 5 ABC Medical Supply Company pays Joe the pharmacist at Neighborhood Pharmacy $25 for every person he refers for medical supplies. Is this a violation of any of the following laws? Beneficiary Inducement Statute False Claims Act Anti-Kickback Act Stark Law Yes. The types of prohibited remuneration covered by the Anti-Kickback Act include bribes and rebates. In addition, prohibited conduct includes remuneration intended to induce referrals of patients, but also, the purchasing, leasing, ordering, or arranging of any good, facility, or service paid by Medicare or State healthcare programs. Which of the following laws mandated creation of a compliance program in every Medicare Advantage Organization? Health Insurance Portability and Accountability Act Anti-Kickback Act Stark Law Balanced Budget Act The Balanced Budget Act mandated creation of a compliance program in every Medicare Advantage Organization. This was the first time the government had required every organization in an entire industry segment to establish compliance programs.

6 The Business Imperative 6 Medicare Advantage (MA) plans are required to implement compliance programs that include mechanisms to prevent, detect, and correct fraud, waste and abuse (FWA) when entering into a contract with the Centers for Medicare & Medicaid Services (CMS). This session will provide an overview of fraud risk management fundamentals, identify new regulatory mandates, and spotlight key CareMore practices utilized in effectively building and maintaining a culture of compliance in the current environment. The Administration and CMS maintain that instances of Medicare fraud and misconduct remain a constant threat to public trust and confidence, therefore an increased area of scrutiny and oversight. CareMore strives to achieve and maintain compliance with an array of practices focusing on efforts to: Understand the fraud and misconduct risks that can undermine business objectives; Determine whether CareMore s antifraud programs and controls are actually effective in reducing instances of fraud and misconduct; Gain insight on better ways to design and evaluate controls to prevent, detect, and respond appropriately to fraud, waste, abuse or misconduct; Reduce exposure to corporate liability, sanctions, and litigation that may arise from violations of law or market expectations; Derive practical value from compliance investments by creating a sustainable process for managing risk and improving performance; and Achieve the highest levels of business integrity through sound corporate governance, internal control, and transparency.

7 An Ongoing Process 7 CareMore s compliance program provides the organization, including its employees, contracted first tier and downstream providers, and related entities with tools to manage risk in a manner consistent with regulatory requirements as well as CareMore s business needs and expectations, utilizing the following approach: Assess Risks. Identify the scope of the analysis and key stakeholders, profile the current state, set targets for improvement, and define steps necessary to close the gaps when identified. Design. Develop a broad ranging program that encompasses controls to prevent, detect, and respond to incidents of fraud or misconduct. Implement. Deploy a strategy and process for implementing the new controls throughout the organization and assign ownership responsibility for leading the overall effort to the appropriate CareMore executive. Evaluate. Assess existing controls compared with legal and regulatory frameworks as well as leading practices, such as internal investigation protocols or due diligence practices. Maintain Audit Readiness. In today s regulatory environment, CareMore must be prepared on an ongoing basis for both focused and routine audits of the Plan.

8 What is FWA? 8 The government is concerned that Medicare Advantage plans are vulnerable to both known and as-of-yet unknown practices that result in fraud, waste, and abuse (FWA). To this end, MA plans are required to implement compliance programs that include a program to prevent, detect, and correct FWA before entering into a contract with CMS. CareMore fulfills its compliance and program integrity obligations before it contracts with CMS, and maintains a robust compliance and FWA detection and prevention program.

9 Defining FWA and Misconduct 9 Fraud is a broad legal concept that generally refers to an intentional act committed to secure an unfair or unlawful gain. CMS defines Waste as the extravagant, careless or needless expenditure of health care benefits or services that results from deficient practices or decisions. Abuse usually involves payment for items or services where there was no explicit intent to deceive or misrepresent, but the outcome of poor, inefficient methods results in unnecessary costs to the Medicare Program. Misconduct, or non-compliance, is also a broad concept, generally referring to violations of laws, regulations, internal policies, and market expectations of ethical business conduct. There are several areas perceived by the government to be prone to a higher level of risk for fraud and abuse in Medicare managed care, including: Benefit Design Enrollment and Post-enrollment Risk Marketing Activities Claims Processing Under-utilization Data Collection and Submission/Reporting Formulary Development Drug Pricing and Rebates Third Party Activities

10 The Core Elements 10 CMS Required Core Elements for an MAPD Compliance Program Written Policies and Procedures and Standards of Conduct Designation of a Health Plan Compliance Officer and implementation of a Compliance Committee Training and Education, including BoD, all employees, first tier and downstream contractors, and related entities Effective Lines of Communication Enforcement of Standards through well publicized disciplinary guidelines Monitoring and Auditing Corrective Action Procedures Comprehensive fraud and abuse plan, including procedures for selfreporting potential fraud or misconduct CareMore s Compliance Program Prevention Detection Response Board Compliance and Audit Committee Oversight Fraud and misconduct risk assessment Compliance Officer and Compliance Committee due diligence Effective Communication and Training Written Policies and Procedures Electronic P&P Library Compliance Plan, Code of Conduct and related standards Senior Management due diligence Employee due diligence First tier, downstream and related entity due diligence Process-specific FWA risk controls PBM due diligence Hotlines and Reporting Mechanisms Auditing and monitoring Proactive data analysis Internal investigation protocols Enforcement and accountability protocols Disclosure protocols Remedial Action Protocols

11 FWA and Misconduct 11 It is important to understand that fraud and misconduct can initiate from many sources, all of which require scrutiny and oversight by the plan. CareMore conducts ongoing analysis in all these areas: The MAO and its employees; Administrative Services Providers, including the Pharmacy Benefit Management Organization (PBM); Medical Providers; (including contracted and non-contracted providers); Pharmacies and Pharmacists; Wholesale Drug Manufacturers; and Medicare Beneficiaries

12 FWA/Misconduct Health Benefit 12 Types of Potential Fraud and Abuse Incidents - Health Benefit CareMore conducts ongoing oversight and monitoring to detect, prevent and correct the following potential incidents that can occur under Part C: Adverse selection - Selecting/denying beneficiaries based on illness profile or other discriminating factors; Attempts to steal beneficiary identity/money - Examples of this include: (1) individual or organization poses as Medicare or Social Security with intent to steal beneficiary's identity or money or (2) individual uses/steals another person's Medicare or MA card; Billing for ineligible consumers - Misrepresentation of beneficiary's personal identity or eligibility information, medical condition, or plan enrollment information; Collusion among providers - Collusion among bidders or providers occurs when a community's competing providers agree on minimum fees charged and capitation rates accepted. This may also include carving up service areas; Providing data to CMS that lacks integrity - Examples of this include: (1) failure to generate or report complete and accurate information upon which government reimbursement depends, in whole or in part or (2) improperly reporting enrollment/disenrollment data to CMS to inflate prospective payments; Discouragement of treatment using geographic or time barriers - An MA Organization or Primary Care Physician (PCP) discourages treatment by requiring beneficiary to use a provider whose office is far from the beneficiary's home, has limited office hours, has long waiting times for appointments, or whose office is difficult-toreach by public transportation; Double-billing or balance billing - This occurs when the provider receives more than one payment for the same service and keeps the money or the provider bills the beneficiary directly for the total amount of the bill including the amount of the charge that the provider has agreed to write off after the MA organization has paid;

13 FWA/Misconduct Health Benefit 13 Types of Potential Fraud and Abuse Incidents - Health Benefit (continued) Failure to provide medically necessary services - Plan sponsor, health care provider, or other entity fails to provide medically necessary items or services that it is required to provide under law or under the contract, and that failure adversely affects, or is substantially likely to affect the beneficiary; Falsification of health care provider credentials - This can occur either at the MA organization or downstream levels. Falsification of provider credentials may result in improper payment for the services of a provider who does not meet required professional qualifications; Falsification of financial solvency - A first tier or downstream entity can purport to have sufficient assets to cover claims when, in fact, it lacks financial solvency. This may result in the failure to pay providers at all or in a timely manner, and thereby affect patient care; Improper coding - (upcoding and unbundling) By using the wrong billing code or unbundling the codes included in a larger, more inclusive set of codes, the health care provider is able to be reimbursed at a higher rate than if the correct billing codes were used and the services were billed together; Improper cost reporting or cost-shifting - For example, providers submit inflated reports of patient traffic and treatment costs in order to induce payers to increase future per-patient capitation fees; Inappropriate physician incentive plans - Under a capitated arrangement, specialists may be paid by PCPs using a portion of the PCP s capitation payment if a referral is made. Fraud can occur if the PCP receiving capitation payment does not reimburse specialists or does not refer members to specialists even if medically necessary;

14 FWA/Misconduct - Health Benefit 14 Types of Potential Fraud and Abuse Incidents - Health Benefit (continued) Inducements, kickbacks, bribes, or tying agreements - Examples of this include: (1) inappropriate discounts, support services, educational grants, research funding; (2) improper entertainment, business courtesies; or (3) the MA organization may subcontract with entities that have expertise in a particular area. If the subcontractor requires the MA organization to contract with other entities as a condition for the subcontractor to provide services, the MA organization could incur inflated costs; Marketing schemes - Plan sponsor, first tier entity, or downstream entity violated Medicare marketing guidelines or other federal or state laws, rules, and regulations to improperly enroll beneficiaries in a Medicare Advantage plan; Overcharging beneficiary - Charging beneficiary more or improper co-insurance or premiums; Outside scope of practice - Physicians provide services outside the boundaries of their scope of practice; and Services never rendered - Provider submits claims or encounter data for services that were never provided to beneficiary.

15 FWA/Misconduct - Health Benefit 15 Entities from Whom Potential Fraud and Abuse Incidents May Originate Health Benefit In its monitoring, CareMore identifies the following individuals or entities that can be responsible for potential fraud and abuse incidents under Part C: Beneficiary or beneficiary relative Durable medical equipment supplier Home health agency Hospice Hospital Physician, nurse practitioner, or other health care professional including mental health professional The Company and its employees Sales Agent (employed or contracted) First tier or downstream entity (other than health care provider)

16 Relevant Examples 16 Is the increased selection of healthy enrollees and a decrease in the selection of unhealthy enrollees examples of inappropriate member selection? Yes, the two most common examples of member selection are medical screening and discrimination marketing. Medical screening is done by directly focusing on an enrollee's past claims and current health, or indirectly on issues such as age, income, and disability, resulting in persons with high claims or poor health are discouraged from continuing with the plan. It is important to note that Special Needs Plans (SNPs) have an exception to the prohibition on health or income screening, only as it applies to qualifying for the SNP. Does the OIG mandate or recommend that all marketing materials are reviewed and approved by CMS prior to use? The OIG mandates review and approval by CMS of all Medicare Advantage marketing materials. These laws are intended to deter inappropriate or coercive practices, such as offering or providing monetary inducements to beneficiaries or using misleading marketing materials. The scope of the term marketing, as used in the Medicare statute and CMS regulations extends beyond the public s general concept of advertising materials, to define marketing materials as including any informational materials targeted to Medicare beneficiaries.

17 Relevant Examples 17 Which of the following is an FWA concern in which MA Plans will reduce costs by withholding, reducing, and/or delaying care to beneficiaries? Disenrollment Marketing Member Selection or cherry-picking Under-utilization Under-utilization is Correct. This is fraudulent in managed care because an organization has already been pre-paid for services through a monthly risk-adjusted payment arrangement, but is not delivering the services they were paid to provide. A Plan sponsor, health care provider, or other entity that fails to provide medically necessary items or services that it is required to provide under law or under the contract, when that failure adversely affects, or is substantially likely to affect the beneficiary, is an FWA concern. Procedures for internal monitoring and auditing allow MA Plans plans to. 1. increase the scope of their marketing efforts 2. identify possible FWA activities 3. prosecute confirmed fraudulent activities to CMS #2 is correct. Procedures for internal monitoring and auditing should test and confirm compliance with MAPD benefit regulations and all applicable state and Federal laws as well as internal policies and procedures.

18 FWA/Misconduct Part D Benefit 18 Types of Potential Fraud and Abuse Incidents - Part D Prescription Drug Benefit CareMore conducts ongoing oversight and monitoring to detect, prevent and correct the following potential incidents that can occur under Part D: Attempts to steal beneficiary identity to obtain prescriptions - Examples of this include: (1) individual uses another person's Medicare or insurance card to obtain prescriptions or (2) beneficiary asked to sell Medicare or MA card for purpose of obtaining prescriptions; Purchase of counterfeit or adulterated drugs through black or grey market - Pharmacy, health care provider, or other entity purchases fake, diluted, expired, or illegally imported drugs; Providing data to CMS that lacks integrity - Examples of this include: (1) submitting inaccurate or incomplete PDE data or Part D plan quarterly data or (2) inappropriate documentation of pricing information; Diverting prescriptions - Examples of this include: (1) beneficiary obtains prescription drugs from a provider and gives or sells this medication to someone else or (2) inappropriate consumption or distribution of a beneficiary's medications by a caregiver or anyone else; Doctor shopping, potential drug abuse, or stockpiling - Examples of this include: (1) beneficiary consults a number of doctors for the purpose of inappropriately obtaining multiple prescriptions for narcotic painkillers or other drugs or (2) beneficiary attempts to game her/his drug coverage by obtaining and storing large quantities of drugs and then disenrolling; Failure to provide medically necessary prescription drugs - Plan sponsor or healthcare provider fails to provide, to a beneficiary, medically necessary prescriptions that the organization is required to provide under law or under the contract, and that failure adversely affects, or is substantially likely to affect the beneficiary; Forged or altered prescriptions or other documents - For example, prescriptions are forged or altered by someone other than the prescriber or pharmacist without prescriber approval, to increase quantity or number of refills;

19 FWA/Misconduct Part D Benefit 19 Types of Potential Fraud and Abuse Incidents - Part D Prescription Drug Benefit (continued) Inappropriate billing for prescriptions - Examples of this include: (1) billing for brand drugs when generics are dispensed; (2) billing for non-covered prescriptions as covered items; or (3) billing for prescriptions that are never picked up; Inappropriate prescribing - Examples include: physicians writing prescriptions outside the boundaries of their scope of practice; off-label prescribing of controlled substances; or prescriber is on the OIG exclusion list; Inappropriate prescription dispensing - Examples of this include: (1) dispensing expired or adulterated prescription drugs; (2) dispensing without a prescription; or (3) splitting - where pharmacist or mail order pharmacy splits prescription to receive additional dispensing fee; Inducements, kickbacks, or bribes - Examples of this include: (1) prescriber is offered, paid, solicits, or receives unlawful payments to induce or reward the prescriber to write prescriptions for drugs or products or (2) PBM receives unlawful payments in order to steer a beneficiary toward a certain plan or drug, or for formulary placement; Overcharging beneficiary for prescriptions - Examples of this include: (1) charging beneficiary for drugs beneficiary did not receive; (2) pharmacy asking beneficiary to pay uncompensated amounts; or (3) bait and switch pricing, i.e., beneficiary is led to believe a drug will cost one price, but at point of sale beneficiary is charged a higher amount; Theft of prescriber's prescription pad or prescriber number - In context of e-prescribing includes theft of provider's login information; and TrOOP (true out-of-pocket) or low income subsidy manipulation - Examples of this include: (1) incorrect TrOOP calculation that results in improper payments by CMS or beneficiary or (2) beneficiary not receiving the low income benefit approved by CMS.

20 FWA/Misconduct - Part D Benefit 20 Entities from Whom Potential Fraud and Abuse Incidents May Originate Prescription Drug Benefit In its monitoring, CareMore identifies the following individuals or entities that can be responsible for potential fraud and abuse incidents under Part D: Beneficiary or beneficiary relative Durable medical equipment supplier PBM Pharmacy or Pharmacist Physician, nurse practitioner, or other prescriber The Company and its employees (most specifically the Pharmacy Department) First tier or downstream entity (other than health care provider, PBM or pharmacy)

21 Internal Reporting of FWA or Misconduct 21 CareMore offers multiple mechanisms to report suspected FWA or misconduct, including: Calling the anonymous Hotline at ; Sending an to In person to employee s supervisor, HR Representative or Plan Compliance Officer* It is the responsibility of every CareMore employee, contractor and agent to perform our duties in the dayto-day operations of the company in a legal, ethical and compliant manner. Failure to do so will result in disciplinary action, up to and including termination of employment or contract. Every attempt will be made to maintain confidentiality of all reports, but may not be guaranteed if law enforcement gets involved. For more information on CareMore s Compliance Program, view the CareMore Compliance Principles and reporting guidelines at Reports may be made anonymously and retaliation is prohibited when a concern is reported in good faith.

22 External Self-Reporting of FWA or Misconduct 22 CareMore s Health Plan Compliance Officer or other authorized CareMore personnel report misconduct, including suspected FWA, to CMS, its designee (e.g. the MEDIC) and/or law enforcement when appropriate. If CareMore determines that material fraud or misconduct related to the Part C program (health benefit) has occurred within CareMore or at the contracted first tier, downstream or related entity levels, the conduct will be referred by the Regulatory Affairs Department (RAD) to the CMS as soon as possible so that CMS or its designees may help identify and address any scams or schemes. Potential fraud or misconduct related to the Part C program may also be self reported to other government and/or law enforcement authorities such as the OIG or the DOJ as appropriate. Actions are taken to correct any discovered internal deficiencies, and follow-up is maintained with outside agencies. MEDICs CMS has contracted with private organizations, called Medicare Drug Integrity Contractors (MEDICs), to assist in the management of CMS audit, oversight, and anti-fraud and abuse efforts in the Part D benefit. Once potentially fraudulent activity is detected under Part D, CareMore s Pharmacy Department, and/or the contracted PBM will thoroughly investigate the matter. If CareMore determines that potential fraud or misconduct related to the Part D program has occurred, the conduct will be referred to the MEDIC promptly by the Pharmacy Department or the contracted PBM. Potential fraud or misconduct related to the Part D program may also be reported as appropriate to government authorities such as CMS, the OIG or the DOJ as appropriate. Actions are taken to correct any discovered internal deficiencies, and follow-up is maintained with outside agencies.

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