AGEWELL NEW YORK, LLC COMPLIANCE PROGRAM CHARTER

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1 AGEWELL NEW YORK, LLC COMPLIANCE PROGRAM CHARTER Managed Long Term Care Plan Medicare Capitated Financial Alignment Demonstration Plan Medicare Prescription Drug Plan Sponsor (Parts C & D) I. INTRODUCTION AND OVERVIEW AgeWell New York, LLC ( AgeWell New York or AgeWell ) maintains a comprehensive Corporate Compliance Program to ensure that it consistently complies with all applicable Federal, State, local laws and regulations, and all the requirements of Federal and State health care programs (including Medicare and Medicaid) in all facets of its corporate activity. Accordingly, AgeWell New York has instituted a Corporate Compliance Program ( Compliance Program ) to govern its operations as a Managed Long Term Care Plan, Medicare Capitated Financial Alignment Demonstration and a Medicare Prescription Drug Plan Sponsor (Parts C & D). The Compliance Program applies to all AgeWell New York Board of Managers, corporate officers, administrative, clinical, and management personnel, contracted health care providers and practitioners and other employees, as well as vendors and First-Tier, Downstream and Related entities ( FDRs. ) AgeWell New York operates a Managed Long Term Care Plan ( MLTCP ), licensed by the New York State Department of Health ( NYSDOH ). The Compliance Program shall govern the activities of AgeWell New York and any of its future subsidiaries and controlled affiliates. All references to the Board in the Compliance Program documents shall refer collectively to the Board of Managers of all such AgeWell New York entities, unless explicitly noted otherwise or unless a particular provision by context is clearly applicable to only a subset of those entities. The primary goal of the Compliance Program is to promote a culture at AgeWell New York of commitment to the prevention, detection and correction of situations that do not conform to applicable laws, rules and regulations, third party payor requirements, and quality of care standards. AgeWell New York is committed to providing the care and services necessary for each member to attain or maintain the highest practicable physical, mental and psychosocial well-being in accordance with his or her comprehensive assessment and plan of care. The Compliance Program is designed to meet the definition of an effective program to prevent and detect violations of law as set forth in the Federal Sentencing Guidelines for organizations. As AgeWell New York s operations grow and change, and as applicable laws, rules and regulations are enacted and amended, elements of the Compliance Program will be modified to address these changes. 1

2 II. WRITTEN POLICIES, PROCEDURES, STANDARDS AND CODE OF CONDUCT A. Commitment to Comply with All Applicable Federal and State Regulations AgeWell has adopted and maintains its Compliance Program to articulate its commitment to complying with all applicable Federal, State and local laws, regulations and guidelines governing its participation as a Managed Long Term Care Plan, Medicare Capitated Financial Alignment Demonstration, and a Medicare Prescription Drug Plan Sponsor (Parts C & D). The Compliance Program conveys AgeWell s commitment to ethical business standards and behavior, promoting a culture of prevention, detection and correction of issues. The Compliance Program seeks and maintains regulatory compliance by addressing each of the compliance elements specified in 42 CFR (b)(vi) and (b)(4)(vi) and associated sub regulations. For meeting New York State requirements, the Compliance Program is aligned with New York State Social Services Law 363-d (SSL 363-d) and its implementation regulations, Provider Compliance Programs found in Part 521 of Title 18 of the New York Code, Rules and Regulations (18 NYCRR). AgeWell s Compliance Program Charter is supported by a comprehensive set of policies and procedures explaining the operation of the Compliance Program. These policies and procedures are updated as necessary to incorporate changes in applicable laws, regulations and other program requirements. B. Standards of Conduct, Code of Conduct and Compliance Expectations AgeWell s Standards of Conduct and Code of Conduct articulate its commitment to conduct business in a lawful and ethical manner, and in compliance with all Federal and State laws, regulations and other requirements. The Standards of Conduct and Code of Conduct summarize AgeWell s compliance expectations, to which all our employees, network providers and contractors must adhere. The Standards of Conduct and Code of Conduct guide AgeWell New York, its Board, managers, employees, contractors, FDRs and others in adherence to legal and ethical standards and practices. These documents provide information on AgeWell s expectations related to good-faith participation in the Compliance Program, how to report compliance issues, and AgeWell s policy of nonintimidation and non-retaliation for good-faith reporting compliance concerns and violations. All AgeWell employees must read the Code of Conduct and sign an acknowledgement that they agree to abide by the Code of Conduct upon hiring. This is generally undertaken during the new hire orientation program, which also includes general compliance training. This acknowledgement is maintained in employees personnel file. We maintain a copy of the Code of Conduct on the AgeWell intranet and in poster form in AgeWell offices for easy access and reference. 2

3 C. Implementation and Operation of Compliance Program AgeWell s Compliance Program is designed, implemented and operated in an organized and structured manner including the following major components: Compliance Program Charter Standards of Conduct, Code of Conduct, Written Policies and Procedures Experienced Compliance Officer supported by Compliance Committee and external resources Comprehensive Training and Education Programs Effective and Reliable Lines of Communication Well-publicized disciplinary standards and enforcement procedures Effective system for routine monitoring and identification of compliance risks Procedures and system for prompt response to compliance issues AgeWell s expectations for compliance are described in compliance specific policies, as well as the policies and procedures of the specific business unit operations, care management processes and systems, and other information and financial systems. Each AgeWell executive, manager and supervisor is responsible for instituting the relevant compliance-related policies and procedures in their respective departments or areas of responsibility. The policies, procedures and practices set forth in the Compliance Program and those related to specific business units/departments shall be adhered to by all employees. D. Guidance on Dealing With Potential Compliance Issues In the event that an employee or contracted provider or FDR suspects that violation of the Compliance Program may have occurred, he or she should immediately notify the Corporate Compliance Officer, the individual s Department Head, assigned AgeWell representative, a member of senior management, or contact the Compliance Hotline. The Compliance Officer, with the assistance of legal counsel if necessary, shall promptly conduct an internal investigation of credible allegations of Compliance Program violations. Preliminary information may be such that the Executive Director should be informed of a potential compliance problem prior to investigation by the Compliance Officer. If the Compliance Officer believes that the presence of employees under investigation may jeopardize the integrity of an investigation, the Compliance Officer may recommend to the Executive Director that the employees be temporarily suspended or temporarily reassigned to another work area. An internal investigation may include interviews and a review of relevant documents. AgeWell New York maintains written and other available documentation sufficient to be able to describe the nature, scope and outcome of any internal investigation that is undertaken. E. How to Communicate Compliance Issues to Appropriate Compliance Personnel AgeWell employees, contractors, providers, and FDRs are required to report any compliance issue of which they become aware. AgeWell maintains the confidentiality of the identity of all individuals who report in good faith, violations of the Compliance Program to the extent possible. 3

4 Options for communicating compliance issues include: Report issue directly to the employee s Department Head, or in the case of FDRs to the assigned AgeWell representative Report directly to the Compliance Officer Reports concerning the conduct of Board members, managers and supervisors should be made to the appropriate individuals who have supervisory authority over such individuals. For example, suspected misconduct involving the Compliance Officer or the Executive Director would be reported to AgeWell s Chairman of the Board of Managers. Call Toll-Free Compliance Hotline and leave a voice message 24 hours day/7 days a week. Messages can be anonymous or contact information can be left so a call can be returned promptly. Hotline reports may be made anonymously, and investigations will be handled in such a manner as to maintain confidentiality to the extent possible. Compliance Hotline files, maintained by the Compliance Officer, shall be located in a secure area to maintain appropriate confidentiality of reported information. If in any of the above communications, a person gives their name, every effort will be made to keep the identity confidential. However, it is possible that the identity may have to be revealed in the course of investigating the reported situation. If identity is revealed, the person may not be retaliated against pursuant to the AgeWell non-retaliation policy. F. How Potential Compliance Issues Will be Investigated and Resolved Upon verifying the factual basis of a suspected violation, the Compliance Officer, after consultation as needed with the Compliance Committee and/or legal counsel, shall recommend an appropriate response promptly to the Executive Director. Corrective action may include: Conducting further investigation of the alleged violation Preparing recommendations for corrective action in the form of a corrective action plan Correcting the practices within the Department or unit which led to the problem Disclosing the matter to government entities Informing the Chair, AgeWell New York Board of Managers, of the matter and the planned response Instituting the appropriate disciplinary action against the employee, contracted provider, FDR, or other party who is involved in the suspected violation Undertaking a program of education within the appropriate Department or unit to prevent similar violations in the future Calculating the amount of any overpayment and determining the method for making the appropriate repayment (except that determinations and corrections of routine, normal course overpayments and underpayments may be undertaken by the Finance Department without the involvement of the Compliance Officer) 4

5 If the Compliance Officer discovers credible evidence that criminal conduct may have occurred, AgeWell New York shall promptly investigate the matter to determine if specific corrective action and/or notification of appropriate government authorities is warranted under the circumstances. All instances in which the Compliance Officer discovers credible evidence of a potential violation of any law, whether criminal, civil or administrative, will be promptly referred to legal counsel to evaluate the seriousness of the allegations and the necessity and timing of any disclosure to appropriate New York and/or Federal authorities. If the investigation reveals that there is systemic non-compliance with Compliance Program requirements, the Compliance Officer shall consult with legal counsel and the Compliance Committee to evaluate: (a) the adequacy of corrective action by AgeWell New York and (b) whether AgeWell New York should modify the Compliance Program to address the identified compliance problem. G. Policy of Non-intimidation and Non-retaliation for Good Faith Participation AgeWell New York does not tolerate retaliation against employees who report potential violations in good faith. We reinforce this policy in AgeWell s Standards of Conduct and Code of Conduct and in various policies and procedures. Retaliation such as suspension, threats, harassment or other discriminatory behavior is not allowed. Any person who attempts to or encourages others to retaliate against another person who has reported a violation in good faith will be subject to disciplinary action up to and including termination of employment. AgeWell is committed to ensuring that no person will suffer retaliation for seeking guidance on how to report a potential violation, or for reporting a violation in good faith. AgeWell expects that individuals who make compliance related reports will do so in good faith, without improper motives. Deliberately untruthful or misleading reports may subject the reporter to disciplinary actions up to and including termination. III. COMPLIANCE OFFICER, COMPLIANCE COMMITTEE AND ACCOUNTABILITY A. Corporate Compliance Officer AgeWell New York shall at all times employ a Compliance Officer, appointed by the organization, who shall: (a) be a member of senior management; (b) report directly to AgeWell New York s Executive Director; (c) have direct access to all senior management and legal counsel; and (d) have direct access to the Board of Managers whenever the Compliance Officer believes that access to the Board is necessary, for example, if reportable conduct pertains to the Executive Director. The Compliance Officer shall have sufficient education, training, funding, staff and authority to ensure implementation of the Compliance Program. The Compliance Officer shall be responsible for coordinating all aspects of the Compliance Program, and shall make reports to the Executive Director and the Board of Managers, as necessary and according to leading practices for the health care compliance field. The Compliance Officer is responsible for coordinating the overall implementation of the Compliance Program, including without limitation the following activities: Consulting with counsel and other appropriate persons in the development and implementation of Policies and Procedures, as well as documents necessary to ensure compliance with all applicable Federal, New York State and local laws, regulations and other applicable 5

6 requirements Working with appropriate AgeWell New York Departments and areas of operation to develop Policies and Procedures to implement the Compliance Program Monitoring changes in statutes, regulations and other requirements, as well as practices in the health care industry relevant to AgeWell New York s operations, and updating Compliance Program documents as necessary Taking steps to ensure that compliance information is effectively communicated and that education efforts are appropriately documented Communicating applicable Compliance Program Policies and Procedures to all employees, FDRs, and contracted providers by distributing relevant documents and/or requiring that they participate in regular education and training programs in compliance-related subjects Assisting in the development of appropriate personnel Policies and Procedures to promote compliance, including consultation with applicable databases In conjunction with each applicable Department, establishing monitoring and auditing systems to identify compliance issues and to evaluate the effectiveness of ongoing compliance efforts Creating a publicized system whereby employees and others can report potential or actual violations of the Compliance Program to management personnel or the Compliance Officer, through a twenty-four hour Compliance Hotline and other reporting mechanisms Systematically responding to compliance questions or concerns (including without limitation any deficiencies identified by government surveys) and coordinating the internal review of possible compliance issues that have been identified In coordination with legal counsel and AgeWell New York s management, responding to all identified compliance violations by formulating appropriate corrective action Reporting on a regular basis to the Executive Director and the Board of Managers on: (a) compliance monitoring and reviewing results; (b) relevant changes in law or industry standards; (c) proposed changes to the Compliance Program documents; (d) disciplinary actions resulting from compliance violations; (e) overall implementation of the Compliance Program, and (f) the status of any investigations by government agencies of which the Compliance Officer is aware. The Compliance Officer shall have the authority to review all documents and other information relevant to the Compliance Program. The Compliance Officer shall be authorized to review AgeWell New York s contracts and other obligations in order to assess compliance with applicable legal requirements and the Compliance Program. Other documentation and information to which the Compliance Officer shall have access includes, but is not limited to: employee records, accreditation and licensing records, enrollee records, billing and financial records, and marketing records. B. Compliance Officer and Compliance Committee Reporting to the Governance Body The Compliance Officer and the Compliance Committee report on a routine basis to AgeWell s Board of Managers during scheduled Board meetings on the activities and status of the Compliance Program. The Board of Managers is responsible for oversight of the Compliance Program. The Board carries out oversight responsibilities by being knowledgeable about the operations and content of the Compliance Program, as well as being kept up-to-date on the latest activities and any changes in 6

7 regulatory requirements. Compliance Committee members are appointed by the Executive Director, and the Compliance Officer shall work closely with the Compliance Committee on structuring and developing annual plans, reviews, needed resources, and performance improvement. The Compliance Committee shall consist of AgeWell employees who are responsible for compliance-related areas. However, in the interest of gaining new perspectives, the composition of the Compliance Committee shall change from time to time. The Compliance Committee is an advisory body that shall be chaired by the Compliance Officer. The Compliance Committee shall assist the Compliance Officer in addressing substantive areas of corporate compliance, including but not limited to compliance with laws, regulations and rules relating to billing, reimbursement, member care, and employment. The Compliance Committee shall assist the Compliance Officer and other appropriate employees in devising specific plans for implementation of a Compliance Program in each Department or area of operation. The Compliance Officer will preside over meetings of the Compliance Committee and shall prepare meeting agendas for the Compliance Committee. Special, unscheduled meetings of the Compliance Committee may be held at the request of the Executive Director, the Compliance Officer, or any two Compliance Committee members. Compliance Committee minutes shall be maintained for each meeting. The following list is illustrative of matters that may be discussed at the Compliance Committee meetings: Significant compliance activities and matters arising during the interim since the last regularly scheduled meeting and the overall status of implementation of the Compliance Program Material submissions to any governmental agency or other regulatory body made during the interim since the last regularly scheduled meeting Developments in laws, regulations and industry practices and consideration of whether any such changes require amendment to, or supplementation of any Compliance Program document Policies and Procedures and internal systems and controls for Departments and program areas Education and training programs and the development and distribution of compliance materials; ensuring adequacy of systems for employees and FDRs to ask compliance questions and report potential instances of Medicare and Medicaid program noncompliance and potential Fraud Waste and Abuse (FWA) confidentially or anonymously (if desired) without fear of retaliation Whether there is a need to modify the Compliance Program in order to ensure the effective prevention and detection of problems in the future. AgeWell New York Executive and Senior Management shall assist the Compliance Officer in implementing the Compliance Program as needed. In particular, management personnel will share responsibility in the following areas: 7

8 Monitoring changes in the industry and in health care program requirements and advising the Compliance Officer regarding the need to alter Policies and Procedures for the areas within the manager s or supervisor s responsibility Evaluating, developing, and maintaining the Policies and Procedures for the areas within the manager s or supervisor s responsibility Incorporating compliance as part of the employee and contracted provider or FDR evaluation process Ensuring that the relevant Compliance Program documents and training and education materials are distributed to all individuals whose duties and activities are governed by the Policies and Procedures set forth in the materials C. Governance Body Oversight and Knowledge Related to Compliance Program and Activities AgeWell s Board of Managers is responsible for the oversight of the Compliance Program and related activities. The Board maintains its knowledge of the Compliance Program, and related activities (both routine and special initiatives and investigation) on an ongoing basis through its regularly scheduled Board meetings, mandatory education and training on an annual basis and through periodic updates on special areas of interest or changes in Federal or State compliance requirements. The Board reviews reports prepared by the Compliance Officer, the Compliance Committee or others, and makes recommendations for the improvement and enhancement of the Compliance Program. The Compliance Officer and Executive Director keep the Board informed on current and planned Compliance Program activities and initiatives, including periodic reports on compliance audits and investigations. IV. EFFECTIVE TRAINING AND EDUCATION PROGRAM A. General Training and Education AgeWell includes compliance training and education as part of the orientation program for new employees, new FDRs and new appointments to Chief Executive, other senior executive positions or governing body member. Such orientation is held within the first 90 days of the start date of the hire or appointment and annually thereafter. For compliance training and education for all employees, appointed positions and FDRs, such programs occur at least annually and more frequently for continuous learning and performance improvement. When needed, compliance training is tailored to meet requirements related to job functions. The formal compliance training and education programs demonstrate AgeWell s commitment to legal and ethical behavior and regulatory compliance. There is an emphasis on prevention, detection, correction and reporting of Fraud, Waste and Abuse (FWA). The compliance training conveys zerotolerance for FWA and misconduct, and the obligation for good-faith reporting of suspected or actual FWA, and noncompliance. AgeWell emphasizes its policy on non-retribution and non-retaliation for good-faith reporting, and the availability of confidential and anonymous lines of communication. 8

9 Compliance Program training includes, but is not limited to, the following subject areas: Description of the Compliance Program, including review of Policies and Procedures, Standards of Conduct and Code of Conduct Evaluating, developing, and maintaining the Policies and Procedures for the areas within the manager s or supervisor s responsibility Incorporating compliance as part of the employee and contracted provider evaluation process Ensuring that the relevant Compliance Program documents and training and education materials are distributed to all individuals whose duties and activities are governed by the Policies and Procedures set forth in the materials AgeWell performs the general compliance training requirements in the following ways: Classroom training Online training such as webcasts or prerecorded educational sessions Telephone conference calls to train groups that cannot attend live classroom Attestations that employees, FDRs or others have read compliance material and/or fulfilled requirements of written test of knowledge AgeWell ensures that education and training efforts are documented, including the attendance of employees, FDRs, and others at such sessions. The Compliance Officer retains the agenda for each session, attendance sign-in sheets, manual checklists and other records. All employees and FDRs must certify that they have received and read the applicable AgeWell Compliance Program documents and agree to abide by them. The Compliance Officer ensures that relevant publications issued by or on behalf of government agencies or other regulatory bodies are identified and distributed to those employees or FDRs as needed. In conjunction with Legal Counsel, the Compliance Officer periodically disseminates official memoranda with new policies and procedures or changes to the Compliance Program as necessary to respond to new Federal or State laws, rules, regulations or industry standards. The Compliance Officer will include such publications and Compliance Program memoranda in training manuals and materials, and will publicize as appropriate in AgeWell newsletters for internal staff and FDRs. B. Compliance and Fraud, Waste and Abuse Training for FDRs FDR agents (for example, office staff and other personnel associated or employed by the FDR), who have met the FWA certification requirements through enrollment into the Medicare program or through accreditation as a supplier of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies ( DMEPOS ) are deemed to have met the FWA training and education requirements. All FDR agents who are not deemed to have met the FWA training and education requirements are required to take FWA training within 90 days of contracting, and annually thereafter. FDRs have the option of using the standardized FWA training and education module available through the CMS Medicare Learning Network (MLN) at or their own substantively equivalent training program to meet AgeWell s FWA training requirements. 9

10 Regardless of the training program used, AgeWell requires FDR agents to complete the FWA training within 90 days of contracting with AgeWell, and annually thereafter. In its Provider Agreement, AgeWell requires that FDRs maintain thorough and accurate records of all completed training in accordance with their written agreement and present such records to AgeWell upon request. V. EFFECTIVE LINES OF COMMUNICATION ENSURING CONFIDENTIALITY AgeWell has established and implemented effective lines of communication as described below. We ensure confidentiality between the Compliance Officer, members of the Compliance Committee, AgeWell employees, managers and Board of Managers, and FDRs. We provide these lines of communication to be accessible to all and allow compliance issues to be reported in good faith via various methods to ensure confidentiality and anonymity as needed. AgeWell strives to make the reporting mechanisms user friendly, easy to access and navigate, and available 24 hours per day. These options provide choices for employees, Board members and FDRs according to their personal communication preferences. When a person reports a suspected compliance issue, AgeWell will let the person know an expected timeframe for a response and confirmation of confidentiality and non-retaliation for good faith reporting, and will also provide progress reports related to the suspected issue. Reporting options accessible to all include: By direct contact with immediate supervisor, or for FDRs to AgeWell assigned representative By telephone, directly to the Compliance Officer By telephone to Compliance Hotline Calls can be made anonymously or the caller can leave his or her name and contact information. This hotline is operated by a third party vendor to ensure confidentiality. The Compliance Officer reviews all call information and determines follow up actions or investigations. By to: corporatecompliance@agewellnewyork.com By letter to the following address: Corporate Compliance Officer 1991 Marcus Avenue Suite M201 Lake Success, NY The various methods available for reporting compliance or FWA concerns and the non-retaliation policy are publicized in the AgeWell offices and provided to all FDRs for publicizing among their employees and agents. Our general compliance training to all AgeWell executives and employees, Board members, and FDRs include the reporting requirements and the available methods for reporting. 10

11 AgeWell makes information related to the Compliance Officer (name, office location and contact information) and applicable laws, regulations and guidance (for employees, Board members, contractors, FDRs) easily accessible. We communicate this information routinely and on a timely basis in the following ways: Website (public and internal) distributions Individual and group meetings with Compliance Officer Internal bulletin boards for employees Newsletters VI. WELL-PUBLICIZED DISCIPLINARY STANDARDS, PROCEDURES AND ENFORCEMENT AgeWell seeks to encourage good faith participation in the Compliance Program by all affected individuals through its well-publicized disciplinary standards. We use the following mechanisms to disseminate these standards: General compliance training: initial, annual and periodic Internal and external newsletters (both for internal staff and external FDRs) Posters in work/office areas AgeWell New York Website Periodic discussions at staff and departmental meetings Communications in writing, via training or conference calls with FDRs Special reports highlighting a case study (maintaining confidentiality of parties) of the imposition of disciplinary standards A. Expectations for Reporting Compliance Issues and Assisting in their Resolution Based on our commitment to ethical and lawful conduct, AgeWell s standards are expressed by specific policies that cover the duty and expectation to report issues or concerns. These policies inform the staff that violations of the Standards of Conduct and Code of Conduct, AgeWell policies and procedures, laws and regulations may result in appropriate disciplinary action, up to and including termination of employment. In the case where someone believes illegal or unethical conduct may have occurred, AgeWell policies and practices provide assurance that reporting such conduct can happen without fear of retaliation. FDRs and their employees/agents are required to adhere to these policies as well. They must make employees/agents aware that failure to adhere to ethical and legal behaviors could result in disciplinary actions up to and including employment or contract termination. AgeWell stresses that everyone subject to the Standards of Conduct and Code of Conduct is required to immediately report any actual or possible violation, whether it is a result of their own conduct or that of another. There is an obligation to report compliance and FWA concerns. There is an 11

12 expectation to assist in the investigation and resolution of the issues. B. Identification of Non-Compliance or Unethical Behavior AgeWell promptly conducts internal investigations of all credible allegations of Compliance Program violations. AgeWell may identify the incident of non-compliance through a variety of sources, including but not limited to self-reporting channels, CMS audits, internal audits, hotline calls, external audits or member complaints. Whenever AgeWell identifies an incident of misconduct, noncompliance or FWA, AgeWell takes prompt action to investigate the matter, determine root cause and outline effective corrective action. Preliminary information may justify informing the Executive Director of a potential compliance problem prior to or during investigation by the Compliance Officer (with or without legal counsel). Internal investigation may include interviews and a review of relevant documents. Documentation is maintained to describe the nature, scope and outcome of any internal investigation that is undertaken. If the Compliance Officer determines that the presence of employees or FDRs under investigation may jeopardize the integrity of an investigation, or that the allegations are of such a serious nature if true, then the Compliance Officer may recommend that the employees or contracts of FDRs under investigation be temporarily suspended, terminated or temporarily reassigned to other work. C. Timely, Consistent and Effective Enforcement of Standards When Non-Compliance or Unethical Behavior is Determined AgeWell seeks to enforce disciplinary standards in a timely, consistent and effective manner. Disciplinary action is appropriate to the seriousness of the violation. Serious or severe performance or conduct problems may result in immediate written notice and/or termination of employment or contract. For employee conduct issues that are not at the level of serious or severe, AgeWell applies a performance improvement process providing a fair, equitable and consistent method of guiding employees to achieve acceptable performance and conduct. FDRs are required to implement the AgeWell Standards of Conduct and Code of Conduct or substantively equivalent policies specifying the ethical and legal standards expected of FDRs. They are made aware that failure to implement and enforce such standards may result in corrective action, up to and including contract termination. Records are maintained for a period of 10 years for all compliance violation disciplinary actions, capturing the date the violation was reported, date of investigation, summary of findings, disciplinary action taken and the date it was taken. AgeWell periodically reviews the records of discipline to ensure that actions are appropriate to the seriousness of the violation, fairly and consistently administered and imposed within a reasonable timeframe. AgeWell s Human Resources standard practices consider issues related to compliance in the employee annual performance review. 12

13 VII. EFFECTIVE SYSTEMS FOR ROUTINE MONITORING AND IDENTIFICATION OF COMPLIANCE RISKS Routine monitoring and auditing are critical elements in AgeWell s Compliance Program. With a focus on the identification of compliance risks, AgeWell uses risk-based elements to develop the metrics for evaluating performance against legal and regulatory standards. Monitoring and auditing are important tools for AgeWell to identify areas that require corrective action for achieving compliance with specific requirements. This process of self-identification and corrective action forms the basis for continuous performance improvement of our compliance and our Compliance Program. AgeWell sets forth its auditing and monitoring activities through an annual, enterprise-wide risk assessment. This risk assessment reviews program risk areas by function and department, establishes metrics for self-reporting and self-audits from the operational areas, identifies corrective action for areas found to be non-compliant, and requires that such corrective action be implemented. Additional sources for the annual risk assessment include: Regulatory risks based on CMS, New York State Department of Health (NYSDOH), New York State Department of Financial Services (NYSDFS) guidance Risks as identified in the OIG and OMIG work plans Audit findings from CMS, NYSDOH, NYSDFS Notices of non-compliance from CMS, NYSDOH Complaints filed with CMS, NYSDOH, NYSDFS Monitoring outcomes from CMS, NYSDOH and NYSDFS Operational unit self-monitoring findings Corrective Action Plan monitoring Compliance risks are also routinely reviewed and addressed via various oversight activities: Compliance Department and Compliance Committee risk reviews: The Compliance Department, in collaboration with the Compliance Committee, reviews the operational departments as part of the overall program to identify and mitigate compliance risks. This is carried out in alignment with the annual risk assessment and compliance work plan. The results of the monitoring and audits are reviewed by the Compliance Officer and staff, business unit leaders and Compliance Committee members. Audit reports are prepared based on this review, and the audited business unit then develops a corrective action plan to address findings. The findings and corrective action plan are reported to senior management and the Compliance Committee. Reports of compliance activities and corrective actions are reported to the Board of Managers on a periodic basis. Business Unit Self-Audits and Monitoring: AgeWell s business units/operational departments are responsible for conducting routine self-monitoring to ensure that functions and performance are in compliance with regulatory requirements. Compliance-related metrics are developed specific to each department, and such metrics are reported to senior management and/or the Compliance Committee for review and oversight. 13

14 Third Party Data Validation Audits: AgeWell contracts with independent third parties to audit AgeWell s processes and operations against Federal, State and other regulatory standards. The results of the third party audits are reported to the relevant business unit leader, senior management, Compliance Officer and/or Compliance Committee. Monitoring and Auditing of First Tier, Downstream and Related Entities (FDRs): AgeWell contracts with various entities to administer and provide Medicaid and MA-PD services on AgeWell s behalf. These FDRs are required to abide by AgeWell s contractual agreements and regulatory requirements. AgeWell oversees the ongoing compliance of FDRs including Pharmacy Benefit Management (PBM), Provider Network Management and others. AgeWell has developed various methods to monitor and audit FDRs, including desk audit reviews, on-site audits, and the review and monitoring of self-audit reports. Departments and managers accountable for FDR oversight ensure that FDRs implement corrective actions on a timely basis. Auditing by Regulators or Other External Parties: Outcomes from the regulatory review and audit process provide AgeWell with valuable information about its overall Compliance Program. AgeWell considers this feedback as an opportunity to identify its compliance risk and areas needing improvement. In cases where a review or audit outcome indicates that AgeWell has not met a regulatory requirement, AgeWell uses the audit findings to perform root cause analysis and develop corrective action plans to address identified areas of noncompliance. As needed, AgeWell also contracts with external companies to perform compliance-related reviews and assist with programmatic changes to maintain compliance. VIII. PROCEDURES AND SYSTEM FOR PROMPTLY RESPONDING TO COMPLIANCE ISSUES A. Timely, Reasonable Inquiries into Evidence of Misconduct Related to Payment or Delivery of Items or Services AgeWell conducts timely and well-documented reasonable inquiries into any compliance incident or issue involving potential Medicaid or Medicare Program non-compliance or potential FWA. This policy is related to AgeWell s operations and those of its FDRs. AgeWell initiates such inquiries, regardless of source as quickly as possible, but no later than two weeks after the date the potential noncompliance or potential FWA incident was identified. AgeWell s procedures related to responding promptly to compliance issues include: Reasonable inquiry is undertaken with a preliminary investigation of the matter by the Compliance Officer or delegated staff member If the issue appears to involve potential Fraud Waste or Abuse (FWA) and AgeWell does not have either the time or the resources to investigate the potential FWA in a timely manner, 14

15 AgeWell refers the matter to the NBI MEDIC within 30 days of the date the potential FWA is identified so that potentially fraudulent or abusive activity does not continue. AgeWell s Compliance Officer routinely monitors for FWA and Medicaid and Medicare Program noncompliance. When serious noncompliance or waste occurs, AgeWell refers the matter to CMS or NYSDOH, as applicable. When potential fraudulent or abusive activity is identified, AgeWell refers the matter to the appropriate MEDIC. Specifically related to identified overpayments, AgeWell will promptly repay overpayments and when appropriate, report the overpayments to the applicable regulatory agency on a timely basis. B. Appropriate Corrective Actions in Response to Potential Violations AgeWell has established and implemented policies and procedures related to undertaking appropriate corrective actions in response to potential noncompliance or potential FWA. The objective of the corrective action is to correct the underlying problem that resulted in a program violation and to prevent future noncompliance. This policy and procedure includes the following: Conduct a root cause analysis to determine what caused or provided opportunity for the FWA, problem or deficiency to occur Development of a corrective action tailored to address the particular FWA, problem or deficiency identified. Corrective actions may include, but are not limited to, revising processes and systems, updating policies and procedures, retraining staff, reviewing system controls and making modifications, and other measures to sustain a compliant state Creation of a corrective action work plan, including resources needed, accountable persons and timeframe for completion of tasks and final implementation of corrective action Require and provide oversight to FDRs in documenting in writing and carrying out corrective actions Conduct independent audits and/or review of FDRs monitoring or audit reports to ensure that FDRs have implemented corrective actions and that they are effective Maintain FDR contract language specifying ramifications of failing to maintain compliance, or engaging in FWA, such as contract termination Maintain thorough and clear documentation of all deficiencies identified and the corrective actions taken Continuous tracking and monitoring of status of open or uncompleted corrective action plans by Compliance Officer or designee. Once corrective action is completed, the Compliance Department validates the corrective action plan by monitoring activity over a period of time to demonstrate effective and sustained compliance. C. Procedures to Voluntarily Self-Report Potential Fraud or Misconduct to CMS or NYSDOH related to Capitated Financial Alignment Program and/or Medicaid Program AgeWell New York will voluntarily self-report potential fraud or misconduct to CMS or its designee and/or NYSDOH related to the Capitated Financial Alignment programs and/or Medicaid program. 15

16 Self-reporting will include potential FWA discovered at AgeWell, and potential fraud and abuse by FDRs, and significant waste and incidents of Medicare and Medicaid program noncompliance. AgeWell will follow these procedures related to self-reporting: Investigate all potential FWA to make determinations whether FWA has occurred. All investigations and determinations will be made within a reasonable period of time If a determination of FWA is made, self-report promptly to CMS and the National Benefit Integrity (NBI) Medicare Drug Integrity Contractors (MEDIC) and/or NYSDOH, if applicable Refer cases involving potential fraud or abuse that meet any of these criteria: (1) Suspected, detected or reported criminal, civil or administrative law violations; (2) Allegations that extend beyond the Part C and D plans, involving multiple health plans, multiple states or widespread schemes; (3) Allegations involving known patterns of fraud; (4) Patterns of fraud or abuse threatening the life or well-being of beneficiaries; and (5) Scheme with large financial risk to the Medicare/Medicaid Programs or beneficiaries Address and follow-up on issues referred to the NBI MEDIC but then returned to AgeWell because they were determined not to be potential FWA (for example, noncompliance or mere error rather than fraud or abuse) Refer potential FWA at the FDR level to the NBI MEDIC so that this agent can help identify and address any scams or schemes Document NBI MEDIC status reports on their investigations; provide updates to the NBI MEDIC when new information regarding the matter is identified; furnish additional requested information within 30 days unless NBI MEDIC specifies otherwise Consider applicability of reporting potentially fraudulent conduct to government authorities such as the Office of Inspector General or the Department of Justice Perform periodic review of self-reported activity and outcomes to determine trends and risk areas, and use these data to strengthen compliance performance When a referral is made to the NBI MEDIC, AgeWell will include this information: Name of AgeWell Compliance Officer Contact information for follow-up Summary of the issue including the basic overview of the matter and any potential legal violations Specific statutes and allegations at issue; identify Federal and State, civil, criminal and administrative code or rule violations Detailed description of the allegations or pattern of Fraud, Waste or Abuse List incidents and issues related to the allegation Background information: (1) contact information for the complainant, the perpetrator or subject of the investigation, and beneficiaries, pharmacies, providers, or other entities involved; and (2) additional background information that may assist investigators, such as names and contact information of informants, relators, witnesses, websites, geographic locations, corporate relationships, networks Perspectives of interested parties, such as AgeWell, CMS, NYSDOH, enrollee 16

17 Data such as existing and potential data sources, graphs and trending, maps, and financial impact estimates Recommendations in pursuing the case such as next steps, special considerations and cautions. 17

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