Independent Living Systems. Code of Ethics & Supporting Documentation For Providers and Subcontractors ILS_COE_FDR

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1 Independent Living Systems Code of Ethics & Supporting Documentation For Providers and Subcontractors Rev. 12/2016

2 Contents ILS Vision, Mission, and Values... 1 Code of Ethics for First Tier, Downstream and Related Entities... 2 Am I an FDR?... 2 Why is This Document Important to Me?... 4 ILS is Here to Help... 8 Fraud, Waste Abuse and Financial Misconduct... 9 Upholding ILS Enrollee Relationships and ADA ILS Anti-Retaliation Policy Duty to Safeguard ILS Enrollee and Confidential Information Compliance Program and Training Requirements for Contracted Health Care Providers Acknowledgement of Receipt of ILS Code of Ethics and Supporting Documentation, Compliance Training Requirements and First Tier Downstream & Related Entities Information Rev 12/2016 Page i

3 ILS Vision, Mission, and Values Code of Ethics and Supporting Documentation The VISION to be the driving force in healthcare innovations The MISSION to significantly impact the quality of life of members by providing innovative health and social support solutions. The VALUES Independent Living Systems (ILS) CARES: I Innovation & Integrity L S Leadership by example Strength C A R E S Commitment to quality Accountability to employees, clients & community Respect for all Efficiency & Effectiveness Sensitivity & Sympathy for those we serve Statement of Non-Discrimination ILS subscribes to the principles of equal opportunity and affirmative action. We do not discriminate on the basis of age, race, ethnicity, religion, mental or physical disability, national origin, marital status, sexual orientation, sex, genetic information, or source of payment in the enrollment of members, the delivery of covered services or items, or the credentialing or contracting of providers. The Company will not tolerate or condone employees or providers that discriminate. Rev.12/2016 Page 1

4 Code of Ethics for First Tier, Downstream and Related Entities ILS Code of Ethics includes the following detailed requirements: Adherence to ethical decision making Promptly reporting suspected and/or actual noncompliance with ILS Code of Ethics and/or policies and procedures Knowledge of Fraud, Waste, Abuse and Financial Misconduct Avoidance of Conflicts of Interest and Personal Financial Gain Foregoing discussions, giving or offering anything of value, including employment, to anyone on ILS behalf, unless otherwise granted permission by law or ILS policy Protecting the sanctity of relationships ILS built with its customers including protecting their health, safety and welfare Abstaining from intimidation and/or retaliation against persons you may interact with on ILS behalf Duties to protect ILS information Compliance with all applicable laws, rules and regulations Maintaining an ethical and compliant work environment Employing or contracting eligible persons/entities ILS duty to investigate suspected or actual violations ILS duty to initiate disciplinary actions when violations occur Distribution of the Code of Ethics Administration and Application of the Code of Ethics Acknowledgement of Receipt of Training Form Am I an FDR? Independent Living Systems, LLC (ILS) follows the definition of First Tier, Downstream or Related Entity (FDR) defined at in the Code of Federal Regulations at 42 CFR and First Tier Entity means any party that enters into a written arrangement, acceptable to CMS, with a Medicare Advantage Organization or Part D plan sponsor or applicant to provide administrative services or healthcare services to a Medicare eligible individual under the Medicare Advantage program or Part D program. Downstream Entity means any party that enters into an acceptable written arrangement below the level of the arrangement between a Medicare Advantage organization (or contract applicant) and a First Tier entity. These written arrangements continue down to the level of the ultimate provider of both health and administrative services. Rev.12/2016 Page 2

5 Related Entity means any entity that is related to a Medicare Advantage organization by common ownership or control and 1. Performs some of the Medicare Advantage organization s management functions under contract or delegation; 2. Furnishes services to Medicare enrollees under an oral or written agreement; or 3. Leases real property or sells materials to the Medicare Advantage organization at a cost of more than $2,500 during a contract period. Healthcare Service Providers and FDRS You are an FDR if you meet one or more of the following: Federal regulations issued by the Centers for Medicare and Medicaid Services (CMS) requires that providers contracted with ILS to provide healthcare services to our enrollees are First Tier Entities. Chapters 9 and 21 of the Medicare Managed Care Manual identifies a number of services that if delegated would qualify an entity as a First Tier entity. This would include delegation of healthcare services. Therefore, if your entity provides healthcare services on behalf of ILS you are a First Tier entity. In the event ILS contracts with you as a hospital group, but do not directly contract with the group s hospitals and other providers, the hospital and other providers are Downstream Entities. This would require the hospital group, as a First Tier entity, to oversee compliance of the Downstream Entities. Administrative Services and FDRs Compliance Program requirements govern the activities of entities that ILS contracts to provide administrative service functions. Examples of administrative service functions include, but are not limited to: Claims processing and support Credentialing Entities that perform credentialing functions on behalf of ILS are considered First Tier entities within the meaning of CMS guidelines. ILS credentials healthcare providers that participate in our network and credentialing services that are done on ILS behalf are codified in a delegation contract. If your organization is or provides any of the following on behalf of ILS you are an FDR: Delegates to a Downstream Agents Broker organizations Pharmacies Non-employee individuals Entities Vendors Rev.12/2016 Page 3

6 Suppliers Why is This Document Important to Me? It is important that FDRs read this information. As a condition of maintaining an ongoing business relationship with ILS, you and/or your organization agrees to comply with this Code of Ethics and all of ILS policies and procedures. These requirements are in place so that ILS is able to comply with its contractual, federal, state and regulatory obligations. If you or anyone from your organization has a question or concern related to compliance with this Code of Ethics please feel free to reach out to the Compliance Officer at or by at Compliance_Reporting@ilshealth.com. ILS maintains a strict policy against antiretaliation to protect our FDRs and encourage them to communicate any concerns or questions they may have. PURPOSE Independent Living Systems, LLC (ILS), bases its success on trust trust that we will uphold the highest ethical standards when providing services to our clients. To help advance and preserve this trust, ILS has developed this Code of Ethics designed to serve as a guide and reference for your behavior as a contracted provider or entity with ILS. Because the business climate is so dynamic and complex, it is difficult to cover everything in one document. This Code of Ethics is designed to outline the behaviors that we require from ILS FDRs, it is not meant to be an exhaustive list of all legal or ethical matters. FDRs must provide either ILS Code of Ethics and Medicare/Medicaid Compliance Policies or your own to all employees and Downstream Entities within 90 days of hire or the effective date of contracting, when there are revisions to these materials and annually thereafter. Evidence of distribution of these materials can be maintained using attestations, training logs, or other means that can readily demonstrate compliance. SCOPE The ILS Code of Ethics provides the guiding standards for our decisions and actions as members of the ILS community. As used in the Code of Ethics, the term FDR(s) includes all contracted persons, entities or vendors. Although the Code of Ethics can neither cover every situation in the daily conduct of the Company s many varied activities nor substitute for common sense, individual judgment or personal integrity, it is the duty of each ILS contracted entity to adhere, without exception, to the principles set forth herein. Rev.12/2016 Page 4

7 Code of Ethics FDR Responsibility ILS s Code of Ethics for FDRs (the Code) applies to all FDR s. The Code is approved by ILS Compliance Committee and is a formal statement of ILS commitment to the standards and rules of ethical conduct. The Code is an FDR specific document that is carved out of ILS Code of Conduct for employees, as required by ILS Compliance Program. Together these document described ILS commitment to preventing the occurrence of unethical or unlawful behavior, stopping such behavior as soon as possible upon discovery, and disciplining employees and/or FDRs who violate the Code as needed. Any FDR who neglects to report a violation may be subject to disciplinary actions. The Code is available anytime upon request. ILS s Code is written in a format that is easy to read, comprehend and summarizes your Managed Care Manual Compliance requirements. Training and distribution of the Code, Compliance Program, and FWA Program occurs within ninety (90) days of contracting, and annually hereafter. Additional training may be required under special circumstances. While distribution methods may vary, receipt is always documented and housed in a secure location for a minimum of ten (10) years. All standards are updated accordingly to applicable laws, regulations, and other program requirements. It is the duty of ILS and each ILS contracted party to uphold all applicable laws and regulations including the Managed Care Manual. All FDRs must be aware of the legal and programmatic requirements and restrictions applicable to their respective contractual obligations. ILS expects each of its contracted partners to refrain from engaging in any activity which may jeopardize the organization. ILS may implement additional programs necessary to further such awareness and to monitor and promote compliance with such laws and regulations. In addition, First Tier entities must oversee its Downstream Entities and document that these entities are compliant with federal, state law, regulatory requirements this Code and ILS policies and procedures. Questions about the legality or propriety of any actions undertaken by or on behalf of ILS should be referred immediately to the Compliance Department or through our various anonymous reporting mechanisms. To enhance such communication, ILS implemented the Compliance/FWA Hotline that can be reached by dialing (866) The Hotline is a dedicated telephone line and voice mailbox that can be used twenty-four (24) hours a day seven (7) days a week, from any location. This number is confidential and has no caller ID capabilities. When calling the hotline be prepared to: (1) Provide as much information as possible about the incident or activity being reported and to provide as much detail as possible, including the first Rev.12/2016 Page 5

8 and last names of the employee(s), provider (s); and/or subcontractor(s) involved and participating in activity/incident (when known). Any contracted party who wishes to report violations or discuss ethical concerns may do so through Compliance Hotline and/or additional reporting mechanisms. Additional reporting mechanisms include but are not limited to: In Writing: A report may be made in writing by filling out the Compliance-FWA Referral Form located on the Shared Drive at this link: Compliance-FWA Referral Form may be anonymously mailed, placed in the employee compliance Referral Box or personally delivered to the compliance department. To report FWA incidents, please fill out the above mentioned form and check the fraud, waste, and abuse (FWA) box. The above mentioned forms may be mailed to: Attn: Compliance Department Independent Living Systems, LLC 5200 Blue Lagoon Drive, Suite 500, Miami, FL In Person: A report may be made in person by contacting the Compliance Department who maintains an open door policy. Fax: (305) or A report may be made by sending a secure to Compliance_Reporting@ilshealth.com. You must include the word secure at the beginning of your subject line. All FDRs are trained on how to identify and report Code violations. Code of Ethics training is conducted within ninety (90) days of hire and annually thereafter. Confirmation of training is housed in a secure location for no less than ten (10) years. All ILS Board Members, employees, and first-tier, downstream, and related entities (FDRs) are required to report any suspected concerns regarding the Code of Conduct, Noncompliance, Fraud, Waste, and Abuse (FWA), Safety Concerns, and HIPAA violation immediately but no later than twenty-four (24) hours using the above mentioned channels. ILS maintains reporting mechanisms that are user friendly, easy to access/navigate, and available 24 hours a day 7 days a week. Rev.12/2016 Page 6

9 ILS has a strict policy on non-intimidation and non-retaliation for good faith participation in the compliance program. All FDRs are protected and allowed to remain anonymous if desired, however ILS may have to reveal identities during the course of a State or Federal Investigation. Anyone who, in good faith, reports possible compliance violations will not be subjected to retaliation or harassment as a result of their reports. Retribution related to reporting of compliance concerns is prohibited and anyone who engages in such prohibited activity shall be subject to disciplinary action. Concerns about possible retaliation or harassment should be reported to the CCO or his/her designee. All such communications will be kept as confidential as possible but there may be times when the reporting individual s identity may become known or may have to be revealed if governmental authorities become involved. Appropriate actions will be taken against those who have violated applicable law, policies, and/or contractual requirements. This is in line with ILS obligation to comply with the Medicare Managed Care Manual Chapter 21, and Prescription Drug Benefit Manual, Chapter 9, published by the Centers for Medicare and Medicaid Services (CMS). ILS expects FDRs to: Educate their staff and Downstreams on compliance with federal, state laws, rules and regulations in support of ILS obligation to comply with the same; Maintain a work environment that promotes everyone to effectively and promptly communicate issues or concerns; Remain uncompromising as it relates to ethical, legal and contractual obligations; and Develop and educate business ethics for your respective organization in light of the services performed to include, but not limited to, ethics, compliance and training. In the absence of a document of your own, ILS encourages you to formally incorporate this document into your business practice. Guiding Principles to Help You Make Ethical, Legal and Complaint Decisions: 1. Your Actions Impact Others whenever you make a decision consider the impact that your course of action will have on you, fellow employees, your business relationship with ILS and your reputation in the community. 2. Ask whether the decision is legal and complies with your contractual obligations as a healthcare provider there is a myriad of state, federal, regulatory and contractual obligations that we all must meet. Make every effort to familiarize yourself with this information so that it informs the decisions that you make as an individual and/or organization. Rev.12/2016 Page 7

10 3. Own the decisions you make everyone has a duty of responsibility for the decisions s/he chooses to make. ILS expects its FDRs to support ILS by maintaining the highest ethical standards for all professional activities. To that end FDRs should not engage in activities that would result in violation of this Code or that would compromise the reputation of ILS. In addition, ILS expects FDRs to continue open communication with ILS and always remember the member is number one priority. 4. When in doubt ask the Compliance Department at ILS has an open-door, freedom of access guiding principle. In addition, FDRs have a responsibility to report suspected and/or actual ethical or compliance violations. ILS highly respects and values its partnerships. Because of the established relationship with each of our vendors, we hope this fosters open communication without fear of retaliation. Indicators of unethical or problematic behavior include: It s better to ask for forgiveness than permission Don t tell anyone but This conversation never happen It won t hurt if it only happens once If you witness this type of communication, you have an obligation to report it. If someone in a supervisory role asks you to perform unethical or noncompliant action report it to the Compliance Hotline immediate. Self-guiding questions to ask yourself include the following: Does this behavior comport with the Code of Ethics? Would this action subject me to disciplinary action for breach of contract and/or state or federal law? Will this cause harm to myself or others? Does this action safeguard confidential and/or proprietary business or patient information? Will this action cause harm to my reputation or the reputation of ILS? ILS is Here to Help Remember ILS maintains a policy against retaliation or intimidation for good faith reporting of suspected and/or actual violations of this Code, policy and procedure, federal, state law or regulation. Resources If you have an issue, concern or question and would like to report a suspected/actual violation: Begin with a leader in your organization, if there is a conflict Escalate to higher leadership within your organization Rev.12/2016 Page 8

11 ILS Compliance Department is always available: Compliance Hotline: Call this hotline is available 24 hours a day 7 days a week, calls can be anonymous and Caller ID capabilities are deactivated to encourage anonymity. All reports are submitted to the Compliance Department for further review and investigation. Report Fraud, Waste or Abuse to or by at Compliance_Reporting@ilshealth.com Privacy and/or Security breach reporting An ILS FDR has a duty to report violations of Privacy or Security within (enter number of days) of discovery. ILS maintains breach reporting documentation that is available upon request. It is important to note that Privacy and/or Security breaches cannot be reported anonymously to comply with federal, state and regulatory requirements. This information can be submitted by: Mail: Independent Living Systems, LLC Attn: Compliance Department, 5200 Blue Lagoon Drive, Suite 500, Miami, FL Fax: (305) Compliance_Reporting@ilshealth.com Fraud, Waste Abuse and Financial Misconduct ILS does not tolerate or condone activity that could constitute Fraud, Waste, Abuse or Financial Misconduct (FWA). ILS FWA Program aims to detect, correct and prevent FWA. FWA impacts the cost and quality of health care. To that end, state and local agencies are focused on ferreting out FWA. Examples of FWA include: Billing for services that were never rendered Billing for a service that has a higher reimbursement rate than the service produced Misrepresenting who provided the service Falsifying or altering claims document electronic, paper Fraud liability could be imputed to you or your organization even if you do not intentionally misrepresent facts, but receive monetary benefits that you are not otherwise entitled. Therefore, FDRs must provide FWA and general compliance training to your employees and Rev.12/2016 Page 9

12 Downstream Entities that you may delegate administrative and/or healthcare service responsibilities. Additional information on FWA is available at here you can download CMS FWA training to satisfy the FWA training requirement. Compliance training must be completed for all individuals and/or entities within 90 days of hire or the effective date of contracting and at least annually thereafter. It is important that FDRs maintain evidence of completion of compliance training. Evidence of completion of training can be maintained using attestations, training logs, or other means that can readily demonstrate compliance. CMS Medicare Parts C & D Fraud, Waste, and Abuse Training and General Compliance Training provides a certificate to demonstrate completion. Entities that are deemed compliant with the FWA through enrollment in Medicare Parts A or B of the Medicare program or through accreditation as a supplier of Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS). If your organization has the FWA certification your organization is not obligated to complete Part 1 Medicare Parts C and D Fraud, Waste, and Abuse Training, but your organization must complete Part 2: Medicare Parts C & D Compliance Training. Your duty to report Every FDR who supports ILS in anyway has a duty to report suspected and/or actual instances of FWA to one of the contacts in the ILS is Here to Help section. Unqualified Persons or Entities The Office of Inspector General (OIG) is granted the authority under sections 1128 and 1156 of the Social Security Act to exclude certain providers from participating in the Medicare and Medicaid Programs. Federal law prohibits Medicare, Medicaid and other federal healthcare programs from paying for items or services provided by person(s) or entity(s) excluded from participation in these programs. This requirement extends to ILS and its FDRs. Therefore, FDRs are prohibited from contracting with or employing any person or entity that has engaged in OIG prohibited conduct. This would include other health care providers, business partners, or employees of your organization. Screenings should be completed at the time of hiring, contracting and on a monthly basis thereafter. FDRs must maintain evidence that these exclusion checks are performed. Evidence of completion of exclusion checks using logs or other means that can readily demonstrate compliance. Rev.12/2016 Page 10

13 If an FDRs employees or Downstream Entities are on one of these exclusion lists, the person or entity must be immediately removed from work directly or indirectly related to ILS and notify ILS immediately. Prohibited conduct that results in exclusion includes: Conviction of a criminal offense associated with health care Inclusion on the OIG s list of excluded providers Inclusion on the Executive Order list of Blocking Property and Prohibiting Transactions with Persons Who Commit, Threaten to Commit, or Support Terrorism Inclusion on the Department of Health and Human Services OIG or the General Services Administration exclusion list Conviction of any felony involving dishonesty or a breach of trust Screenings can be conducted using: Office of Inspector General (OIG) List of Excluded Individuals and Entities General Services Administration (GSA) System for Award Management (SAM) Conflicts of Interest A conflict of interest is a conflict between the private interests of an FDR and his or her responsibilities as an FDR of ILS. All FDRs have a duty to avoid conflicts with the interests of ILS and may not use their positions and affiliations with ILS for personal benefit. All such conflicts should be avoided. FDRs are prohibited from placing him/herself in a position that would have the appearance of being, or be construed to be, in conflict with the interests of ILS. An FDR must promptly disclose actual or potential conflicts of interest annually and/or when there is a change in an FDRs status related to potential/actual conflicts of interest. Conflicts of interest could arise when there is a personal, familial or business relationship that may impact your entity s ability to fulfill contractual requirements. Moreover, FDRs are required to avoid activities that directly or indirectly compete with any of ILS lines of business or invest in enterprises that select, manage or evaluate as an entity supporting ILS. If you or someone at your organization suspect a conflict of interest may exist please feel free to reach out to us and we will provide you with ILS Conflict of Interest Questionnaire. Gifts and Gratuities FDRs should not accept or provide gifts, entertainment or gratuities from/to customers, contractors, vendors and suppliers and similarly situated third parties if (1) it will influence the FDRs business decisions; or (2) the acceptance of the gift gives the appearance of improper influence in dealing fairly with customers, contractors, vendors, suppliers or others. Rev.12/2016 Page 11

14 ILS prohibits the acceptance of money under any circumstances. An FDR may not accept or solicit a gift of any kind from a customer, supplier or vendor representative. Moreover, FDRs should not offer or provide, directly or indirectly, any remuneration, which means anything of value, to include: job, cash, bribes or kickbacks to any ILS employee, enrollee, contractor, vendor or supplier. Gift giving is limited to $50 or less according to the gift s fair market value. Gifts include, but are not limited to, meals, favors, travel, tickets or entertainment, prizes, drawings, raffle winnings, gratuities and awards. Upholding ILS Enrollee Relationships and ADA Cultural Competency and ADA FDRs who are in contact with ILS customers, including enrollees, are required to interact with these individuals in a culturally competent manner. This includes compliance with the American s with Disabilities Act. This includes: Identifying enrollees that may have cultural or linguistic barriers for which alternate communication methods can be made available; through telephone and/or face to face encounter by a call agent or nurse. Ensuring that enrollees with linguistic barriers receive linguistically appropriate services; Offering and providing language assistance services, including bilingual staff and interpreter services, at no cost to each client with limited English proficiency at all points of contact, in a timely manner during all hours of operation; Working with participating providers to ensure that they are meeting the members culturally diverse needs; Ensuring that FDRs employees are educated and acknowledge the value of diverse cultural and linguistic differences of the population served; Ensuring that our FDRs value the diversity of cultures within the organization and the membership we serve and behaves accordingly. The ADA covers over 500 known disabilities. Disabilities include but are not limited to vision, hearing, speech, amputations, physical and developmental. FDRs and Providers are required to comply with the ADA. Disabilities should be viewed as challenges and not burdens. Ensuring FDRs put the person first and not the disability by not referring to enrollees by their disability. Abuse, Neglect and Exploitation FDRs are responsible for protecting the health, safety and welfare of enrollees. To protect the health, safety and welfare of enrollees, FDRs must be able to identify: Abuse which could be physical, sexual or emotional Neglect which could be behavior that results in serious physical or emotional injury Rev.12/2016 Page 12

15 Exploitation which could be the use of one s position of trust or influence to deceive or coerce or deprive the enrollee of resources, funds or the like Particular groups of people i.e. the elderly or disabled or more susceptible to the aforementioned abuse. Reporting suspected or actual abuse, neglect or exploitation If an ILS enrollee is in immediate danger, call 911 or the local police authority. In addition, FDRs may, in accordance with State law, be required to report suspected abuse, neglect and exploitation directly to the applicable state agency. FDRs are also required to report indications of abuse, neglect or exploitation to ILS Care Manager, who will conduct a further review and proceed with the required action(s). ILS Anti-Retaliation Policy ILS maintains a non-retaliation policy for good faith reporting of suspected or actual violations of this Code, policy or procedure, FWA or federal, state law or regulation. FDRs are also required to maintain a zero tolerance policy for retaliation or intimidation against anyone who reports suspected misconduct. FDRs are expected to work with ILS Compliance Department in efforts to investigate and properly resolve reported matters. ILS will, to the extent allowed by law, maintain your anonymity. Please see the ILS is Here to Help section for reporting methods. It is ILS policy to: 1. Encourage individuals to disclose non-compliance, FWA, and wrongful conduct engaged in by others to the Compliance officer and/or Compliance Department so that prompt, corrective action can be taken by ILS; 2. Inform individuals how allegations of non-compliance, FWA, and wrongful conduct can be disclosed; 3. Protect individuals from reprisal by adverse action or other retaliation as a result of having disclosed non-compliance, FWA, and wrongful conduct; and 4. Provide individuals who believe they have been subject to reprisal or false allegations a fair process to seek relief from these acts. ILS has to a duty to report, when deemed appropriate, to the requisite federal or state authorities to remain complaint with its federal, state and regulatory requirements. ILS will fully and thoroughly investigate all reported violations and take appropriate action as necessary. Rev.12/2016 Page 13

16 Disciplinary Action ILS has a specific policy and procedure for the timely, consistent, and effective enforcement of disciplinary standards. After an investigation, if the concern requires disciplinary actions, the disciplinary process will proceed according to ILS procedures. As it relates to Providers, ILS initiates a thorough investigation and provides warnings, retraining, Performance Improvement Plans (PIPs), Corrective Action Plans (CAPs) or termination of the relationship depending on the severity of identified behavior. In addition, ILS engages the appropriate level of state and federal regulatory and legal authorities to maintain compliance with its legal and ethical obligations. ILS has an obligation to comply with federal, state and regulatory requirements. Failure to do so on ILS part could subject the organization to criminal or monetary penalties or disciplinary action. Therefore, it is recommended that FDRs enforce disciplinary action throughout its organization to encourage compliance and prevent sanctions. Examples of behavior that could subject you to disciplinary action include: Failure to promptly report a suspected violation of this Code Sanctioning or supporting conduct that is in violation of this Code Failure to cooperate in an investigation Failure to oversee compliance within your organization Retaliating against an individual who in good faith reports a suspected violation Duty to Safeguard ILS Enrollee and Confidential Information ILS is obligated to safeguard protected health information required by the privacy and security rules codified in the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economics and Clinical Health Act (HITECH). ILS, in turn, imputes this same obligation upon its FDRs. Policies and Procedures To assist our FDRs in understanding their duties we provide you with trainings and our policies and procedures, which you are required to uphold. These policies and procedures were created to be able to proactively detect and prevent, and when necessary, report, investigate and track uses and disclosures of protected health information (PHI) and noncompliance with state, federal law and regulations. ILS expects its FDRs to maintain its own core set of policies and procedures to include but not limited to: Rev.12/2016 Page 14

17 Privacy and Security training for FDR employees and its contracted entities Non-Disclosure/Confidentiality agreements, when necessary Procedures to properly return or destroy PHI Restrictions on marketing and the use of PHI FDRs are required to fully comply with federal and state regulators and auditing agencies by providing accurate and complete information. Maintain Open Communication FDRs who have questions about how to respond to an audit request or other concerns on the release of ILS data should contact ILS Compliance Officer at ext Permitted and Unauthorized Disclosure Before an FDR discloses ILS enrollee and/or other confidential information, written consent and approval must be obtained from ILS. This includes any FDR contractor, subcontractor, independent contractor or disclosures outside of the United States. Privacy or Security Breach Reporting Contracted FDRs with ILS owe a duty to report any breach by your organization to ILS within five days of discovery of the breach using one of the methods in the ILS is Here to Help section. Offshore operations and CMS Reporting FDRs are prohibited from offshoring, or delegating responsibilities to entities outside of the United States or United States Territories (American Samoa, Guam, Northern Marianas, Puerto Rico, and Virgin Islands), services for any of ILS lines of business. Offshoring is strictly prohibited unless expressly agreed to in writing in advance of offshoring the responsibility. FDRs should notify ILS immediately using the methods identified in the ILS is Here to Help section if it plans to offshore services. Relevant Laws and Regulations There is a myriad of laws and regulations that guide ILS operations that you, as an FDR, should familiarize yourself with to maintain contractual compliance with ILS. These laws include, but are not limited to: Stark Law Anti-Kickback Statute Retaliation against those who report suspect/actual violations Rev.12/2016 Page 15

18 Financial misconduct including, but not limited to, False Claims, money laundering, financially supporting prohibited groups Contracting with prohibited persons/entities Bribing government officials ILS Compliance Department should be timely apprised of allegations of violation or citation from a governmental authority. The person receiving the notification should direct the request to ILS Compliance Department, if the matter involves one of ILS lines of business. Contact methods are available in the ILS is Here to Help section. FDRs to comply with contractual requirements with ILS must not: Destroy or alter documents in anticipation of or during a governmental investigation Provide false or misleading information to government authorities Encourage others to provide false or misleading information to government authorities ILS will conduct oversight of its FDRs through monitoring and auditing to comply with CMS. As an FDR you are expected to fully comply with ILS initiated monitoring and auditing exercises. In turn, FDRs that subcontract delegated functions involving any of ILS lines of business must conduct oversight of its Downstream Entities. Distribution of Code ILS FDRs receive the Code upon generation, within ninety (90) days of contracting if subsequent to implementation of Code, whenever the relevant Code provisions are updated, and annually thereafter. ILS may also distribute the Code to all third party agents and contractors who act for or on behalf of ILS and to vendors who conduct significant business with ILS. FDRs must maintain evidence of compliance with this Code and CMS requirements. Each year a representative from your organization must attest that your organization including employees, contracted entities, providers and vendors are compliant with CMS and ILS contractual obligations. This information should be maintained for a 10 years and may be requested by ILS for auditing and monitoring purposes. Administration and Application of the Code The ILS Compliance Department is responsible for the administration and application of the Code. The Compliance Committee delegates the day-to-day responsibility for administering and interpreting the Code to the Compliance Officer. The Code is incorporated into the daily activities of everyone in the Company with the assistance of Human Resources. Any question about the Code should be directed to his or her immediate supervisor or to the Compliance Department. Rev.12/2016 Page 16

19 Failure to comply with any provision of the Code subjects the FDR to disciplinary measures, up to and including termination of Business Associate Agreement. Should any FDR become aware that one of its employees has violated the Code, he or she is obligated to report the violation to the Compliance Department, Compliance/FWA Hot Line, 1(866) , and/or other reporting mechanisms. No one has authority to retaliate against any FDR who in good faith reports a possible violation. Compliance Program and Training Requirements for Contracted Health Care Providers Frequently Asked Questions and Answers 1. Q: Does this requirement apply to my organization? A: Yes, if you are an Independent Living Systems, LLC (ILS) participating Medicare and/or Medicaid provider. 2. Q: What compliance information does ILS require from health care providers? A: The Centers for Medicare & Medicaid Services (CMS) mandates that all ILS-contracted health care providers complete compliance program requirements. The purpose of our notification is to provide our Compliance Policy for Contracted Health Care Providers and Business Partners (Compliance Policy); Code of Ethics for Providers and Subcontractors (Code of Conduct) and the CMS-published Fraud, Waste and Abuse Training and General Compliance Training, so health care providers and vendors can confirm acknowledgment of the receipt and understanding of, and compliance with, these documents. This confirmation helps these contracted entities meet their contractual obligation to comply with CMS requirements and ILS policies and procedures. 3. Q: What is a first-tier, downstream or related entity (FDR)? A: FDR is a CMS term adopted by ILS, and this guidance document is for ILS FDRs. An FDR is essentially anyone or entity performing work on ILS behalf in an administrative or health care services capacity in relation to Medicare and/or Medicaid. The term FDR includes, but is not limited to, contracted health care providers, pharmacies, delegated entities, delegated agents, suppliers and vendors (see definition below). 4. What do I need to do to fulfill this requirement? A: Please review the compliance materials provided and complete the ILS Attestation Form which must be completed and provided to your contracting representative. 5. Q: Why is ILS requiring me to do this? Rev.12/2016 Page 17

20 A: CMS requires that all those contracted to support Medicare and/or Medicaid products complete required compliance program information upon initial contract and at least annually thereafter. 6. Q: Who should complete this for my organization? A: Someone authorized to complete attestations and acknowledgments related to compliance on behalf of your organization should complete these requirements. 7. Q: Which health care practitioners in our organization are required to complete the requirements and attestation form? A: The requirements and the corresponding attestation form are intended to be completed at the contract level; so, if any health care practitioner in your organization has a direct contract with ILS, then he or she is asked to complete the requirements, which include each submitting a separate attestation form to ILS. However, if your organization is contracted with ILS through a group contract, please coordinate within your organization to have one person responsible for compliance complete the requirements for the organization and submit the attestation form to ILS. 8. Q: Are these one-time requirements? A: No, these are not one-time requirements. CMS requires that this information be completed upon hire or contract and annually thereafter. ILS will provide notification annually as a reminder that all ILS-participating Medicare practitioners delivering health care services to Medicare and/or Medicaid members, as well as contracted vendors performing one or more functions in support of Medicare and/or Medicaid products, must complete these requirements. 9. Q: My organization is deemed for fraud, waste and abuse (FWA) training and education requirements? Why do I have to do this? A: ILS acknowledges that health care providers enrolled in the Medicare program or accredited as a durable medical equipment prosthetics, orthotics and supplies (DMEPOS) provider are deemed to have met the FWA training and education requirements. If applicable, you will have an opportunity to record that your organization is deemed for the FWA requirement. This means you must still complete the ILS Attestation Form to demonstrate compliance with the FWA training requirement and confirm your receipt, understanding and compliance with these other requirements: Compliance Policy, Code of Conduct and CMS general compliance training. 10. Q: My organization has its own similar documents and training, or we have already completed similar training and education from another organization. Do I still have to do this? A: Yes, you still have to confirm to ILS that your organization has completed the following compliance program requirements: Rev.12/2016 Page 18

21 General Compliance Training and FWA Training; Starting January 1, 2016, only the CMS published training document may be used by non-deemed organizations to meet the FWA training and general compliance training requirements Compliance Policy; and Code of Conduct. You will have an opportunity to record on the ILS Attestation Form that your organization has already completed these requirements through another method for all of the above except for FWA training and general compliance training. For these last two trainings, you must attest to meeting these requirements using the CMS training document, although you may supplement it with other documents specific to your organization and the type of work it performs. 11. Q: Where can I get more information about the CMS requirements? A: Requirements for those subject to CMS oversight such as ILS and their first-tier, downstream or related entities, which include contracted health care providers, are outlined in Title 42 of the Code of Federal Regulations, Part In addition, there is guidance in Chapter 9 of the CMS Prescription Drug Benefit Manual and Chapter 21 of the Medicare Managed Care Manual. 42 C.F.R CMS Prescription Drug Benefit Manual, Chapter 9 CMS Medicare Managed Care Manual, Chapter Q: I am enrolled in the Medicare program as a participating provider or am accredited as a DMEPOS provider. Therefore, I have been deemed to have met the FWA training and education requirements. Why is ILS requiring me to complete the Compliance Policy and Standards of Conduct components of the training? A: FWA training addresses only that topic. The two documents listed above outline additional compliance program requirements of both CMS and ILS. The ILS Attestation Form gives you the opportunity to record your deemed status for the FWA portion of the requirements, along with how your organization meets these additional requirements. 13. Q: What will happen if I do not fulfill this requirement? A: If you do not fulfill this requirement, you will be out of compliance with ILS requirements, which may result in disciplinary action up to termination of your agreement or contract. 14. Q: What if I have a question that is not addressed in this FAQ? A: Additional questions about these requirements may be directed to your contracting representative or contact the ILS Compliance Department. Rev.12/2016 Page 19

22 Acknowledgement of Receipt of ILS Code of Ethics and Supporting Documentation, Compliance Training Requirements and First Tier Downstream & Related Entities Information While distribution methods may vary, confirmation of training and the distribution of this code is always documented and housed for a minimum of 10 years. FDRs must maintain evidence of your compliance with the Managed Care Manual Chapters 9 and 21 for no less than 10 years. Moreover, each year, a representative from your organization is required to attest to compliance with the Managed Care Manual, this Code and ILS policies and procedures. The representative must be in a position to oversee and be responsible directly or indirectly for all: Employees Contracted personnel Providers/practitioners Vendors who may provide healthcare/administrative services for ILS I, (First and Last Name) acknowledge the receipt of the ILS Code of Ethics Training, completion of the Providers and Subcontractors Assessment, and a copy of the ILS Code of Ethics for FDR. I understand the ILS Code of Ethics and agree to comply with the requirements. I understand that my failure to comply with the requirements of the ILS Code of Ethics may subject me to disciplinary action which may include termination of the business relationship. FDR Entity Name: Signature: Rev.12/2016 Page 20

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