Standards of Conduct for First Tier, Downstream, and Related Entities (FDR)

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1 Standards of Conduct for First Tier, Downstream, and Related Entities (FDR) The Health Plan National Road East St. Clairsville, Ohio , TDD: , healthplan.org

2 The Health Plan Compliance Guidelines and Standards of Conducts for First Tier, Downstream, and Related Entities (FDR) (revised 1/2015) Contents Section Page Section I Introduction 3 Section II Definitions 3 Section III Compliance with Laws and Regulations 6 Section IV Medicare Compliance Program & Attestations requirements for FDRs 8 Section V Violations of These Standards of Conduct 15 Section VI Required Attestations 15 2

3 I. Introduction The Health Plan encourages and promotes integrity, and an ethical, efficient and compliant approach to health care delivery and to management services, and is committed to conducting its business interactions with the highest ethical standards, in compliance with all applicable federal and state laws and regulations. In furtherance of this approach towards health care delivery, The Health Plan has implemented a Compliance Program to ensure that The Health Plan is compliant with applicable laws, rules and regulations; as well as reinforcing The Health Plan s commitment to compliance. The Centers for Medicare and Medicaid Services (CMS) requires that The Health Plan s First Tier, Downstream and Related Entities (FDR) fulfill specific Medicare Program requirements. The Code of Federal Regulations (C.F.R.) explains in detail the Medicare Compliance Program requirements and further described in the Medicare Managed Care Manual, Chapter 21- Compliance Program Guidelines and Prescription Drug Benefit Manual, Chapter 9-Compliance Program Guidelines released by CMS. These FDR Compliance Guidelines and Standards of Conduct are being provided to you because you have been identified as a FDR that must comply with CMS Medicare Compliance Program requirements. FDRs are expected to adhere to these Standards of Conduct when conducting business on behalf of The Health Plan. While reviewing the Standards of Conduct, FDRs and their employees should keep in mind that ethical behavior and legal compliance begin with some guiding principles: Honesty and integrity are expressed through truthfulness, objectiveness and freedom from deception or fraud. These qualities should remain consistent in any situation, whether involving day-to-day operational staff, management staff or officers of The Health Plan or its FDR. Books, records and documents created and maintained for the furtherance of The Health Plan s business must be accurate and properly maintained. FDRs have a responsibility to use the authority delegated to them in the best interest of The Health Plan and to adhere to the standards set forth herein. 3

4 There should be no conflicts between business operations and attention to ethics and integrity, as these foster a continued positive relationship with The Health Plan. ll. DEFINITIONS The Health Plan has adopted CMS definitions to define FDRs: 4 A. FDR means First Tier Downstream or Related Entity. B. First Tier Entity is any party that enters into a written arrangement, acceptable to CMS, with a Medicare Advantage Organization or Part D plan sponsor or applicant to provider administrative services or health care services to a Medicare-eligible individual under the Medicare Advantage Program Part C and/or Part D program. (See 42 C.F.R & ) C. Downstream Entity is a party that enters into a written arrangement, acceptable to CMS, with persons or entities involved with the Medicare Advantage benefit or Part D benefit, below the level of the arrangement between a Medicare Advantage Organization or applicant or a Part D plan sponsor or applicant and a first tier entity. The written arrangements continue down to the level of the ultimate provider of both health and administrative services. (See 42 C.F.R & ). D. Related Entity means any entity that is related to a Medicare Advantage Organization (MOA) or Part D sponsor by common ownership or control and 1. Performs some of the MOA or Part D sponsor 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 MOA or Part D plan sponsor at a cost of more than $2,500 during a contract period. (See, 42 C.F.R ). All of the Medicare Compliance Program requirements described in this FDR Guideline apply to anyone contracted with The Health Plan who provides administrative or health care services to our enrollees. Here are the reasons why:

5 1. Medicare Advantage (MA) regulations and CMS rules clearly state providers contracted with The Health Plan to provide health care service to our Medicare members are designated as First Tier Entities. According to the CMS definition. 2. Chapter 9/21 of the CMS Manuals includes Healthcare Services in the list of examples of the types of functions that a third party can perform as it relates to a MA organization s contract with CMS and would give them first tier entity status. (Refer to Chapter 9/21, Section 40 of the CMS Manual.) These compliance programs requirements apply to providers that actually deliver health care services to Medicare members. 3. A chart is contained in Section 40, Chapter 9/21 of the Manual that clarifies entities providing health services and hospital groups are first tier entities. If The Health Plan is contracted with a hospital group and does not have a direct contract with the group s hospital and other providers the group is considered a Downstream Entity and is obligated to ensure that its downstream entities comply with CMS compliance program requirements that are stated in this FDR Guideline. Medicare Compliance Program requirements described in this Guideline apply to entities with which The Health Plan s Medicare Advantage or Part D contracts with CMS (e.g., claims processing, patient management, credentialing, etc.) for example, under our Medicare Advantage contract with The Health Plan, we are required to credential health care providers that participate in the Medicare lines of business. The Health Plan contracts with entities to perform these credentialing services on our behalf under a delegation agreement, CMS considers these delegated credentialing entities to be First Tier Entities. Please refer to Chapter 9/21 Section 30 of the CMS Manual which identifies credentialing in the Stakeholder Relationship Flow Chart as a First Tier relationship. In addition, in Section of Chapter 11 of the CMS Medicare Managed Care Manual, CMS identifies delegated credentialing entities as first tier entities. Other examples of FDRs include delegates, agents, broker organizations, pharmacies, and other individual entities, vendors or suppliers contracted 5

6 to provide administrative and/or healthcare services for our Medicare lines of business. III. Compliance with Laws and Regulations A. The Health Plan expects FDRs to operate in accordance with all applicable federal and state laws, regulations and Medicare program requirements including, but not limited to the following: (i) Title XVIII of the Social Security Act Title XVIII of the Social Security Act established regulations for the Medicare program, which guarantees access to health insurance for all Americans, aged 65 and older, younger people with specific disabilities, and individuals with end stage renal disease. Title XVIII includes provisions regarding the collection, disclosure, and use of Medicare beneficiaries health information. (ii) Medicare regulations governing Parts C and D (42 C.F.R. 422 and 423 respectively) a. 42 CFR 422: Medicare Advantage program. This regulation implements the Medicare Advantage Program under the Social Security Act. b. 42 CFR 423: Prescription drug program. This is the established regulation that implements the prescription drug program under the Social Security Act. 6

7 (iii) Federal and State False Claims Acts (31 U.S.C ) The Federal False Claims Act (FCA) prohibits any person from engaging in any of the following activities: a. Knowingly submitting a false or fraudulent claim for payment to the United States government; b. Knowingly making a false record or statement to get a false or fraudulent claim paid or approved by the government; c. Conspiring to defraud the government by getting a false or fraudulent claim paid or approved by the government; or d. Knowingly making a false record or statement to conceal, avoid, or decrease an obligation to pay or transmit money or property to the government. (iv) Federal Criminal False Claims Statutes (18 U.S.C. 287,1001) Federal laws make it a criminal offense for anyone who makes a claim to the United States government knowing that it is false, fictitious, or fraudulent. This offence carries a criminal penalty of five years in imprisonment and a monetary fine. (v) Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)) This statute prohibits anyone from knowingly and willfully receiving or paying anything of value to influence the referral of federal health care program business, including Medicare and Medicaid. This can take many forms, such as cash payments, entertainment, credits, gifts, free goods or services, the forgiveness of debt, or the sale or purchase of items at a price that is inconsistent with fair market value. It may also include the routine waiver of copayments and/or co-insurance. The offense is classified as a felony and is punishable by fines of up to $25,000, imprisonment for up to five years, civil money penalties up to $50,000, and exclusion from participation in federal health care programs. 7

8 (vi) The Beneficiary Inducement Statute (42 U.S.C. 1320a-7a(a)(5)) Makes it illegal to offer remuneration that a person knows (or should know) is likely to influence a beneficiary to select a particular provider, practitioner, or supplier, including a retail, mail order or specialty pharmacy. (vii) Physician Self-Referral ( Stark ) Statute (42 U.S.C. 1395nn) The Stark Law provides criminal penalties for individuals or entities that do not adhere to the regulations regarding financial arrangements between referring physicians (or a member of the physician s immediate family) and entities that provide designated health services payable by Medicare or Medicaid. It does not require any showing of the wrongdoer s intent. (viii) Health Insurance Portability and Accountability Act The Health Insurance Portability and Accountability Act (HIPAA) of 1996 was developed as part of a broad Congressional effort to reform health care. HIPAA was developed to satisfy many purposes, such as the transference of health insurance, the reduction of fraud and abuse and the improvement of access to long-term care services. However, the regulations regarding the simplification of the administration of health insurance is the area that has the greatest impact on the Plan. (ix) Fraud Enforcement and Recovery Act (FERA)of 2009 FERA makes significant changes to the False Claims Act (FCA). FERA makes it clear that the FCA imposes liability for knowing an improper retention of a Medicare overpayment. Consequently, a health care provider may now violate the FCA if it conceals, improperly avoids or decreases an obligation to pay money to the government. 8

9 (x) Prohibitions against employing or contracting with persons or entities that have been excluded from doing business with the federal government. (xi) Other applicable criminal statutes. (xii) All sub-regulatory guidance produced by Centers for Medicare & Medicaid Services (CMS) such as manuals, training materials, Health Plan Management System (HPMS) memos, and guides. (xiii) Contractual commitments. B. Any violation or suspected violation of the above mentioned regulations must be reported promptly to The Health Plan. Please refer to Section 7, page 5 for guidance on how to report potential issues of noncompliance. IV.Medicare Compliance Program and Attestations Requirements for FDR The Health Plan is committed to ensuring that our designated FDRs are in compliance with applicable laws, rules and regulations. The Health Plan is ultimately responsible for fulfilling the terms and conditions of our contract with CMS and meeting applicable Medicare program requirements. Hence, The Health Plan requires each FDR to comply with the Medicare Program requirements. If it is determined by The Health Plan that an FDR has failed to meet CMS Compliance Program requirements, this may result in a Corrective Plan Action, further training, or termination of the delegation agreement with an FDR. The action taken for noncompliance will vary depending on the severity of the compliance issue. Example: If a first tier entity identifies any area of noncompliance such as an employee refuses to complete the required FWA training, the first tier entity is required to take prompt action to both correct the deficiency and prevent future occurrence. You have been identified as a FDR and you and your organization including all of your downstream entities (if applicable) are required to 9

10 comply with CMS Compliance Program requirements this includes but are not limited to the following: Fraud, Waste and Abuse (FWA) training and general compliance training and Code of Conduct (COC)/compliance policies disseminated. Exclusion List Screening (OIG, GSA /SAM) Reporting of FWA and compliance concerns to The Health Plan Offshore operations and CMS reporting Monitoring and auditing of FDRs Specific federal and state compliance requirements This FDR Compliance Guideline summarizes your Medicare Compliance Program responsibilities. Ensure you have internal processes to support compliance with these requirements each calendar year. As a FDR entity you are required to retain evidence of your compliance with the Medicare Compliance Program requirements (e.g. employee training records, CMS certificate of FWA training completion, etc.) for 10 years from the final termination of any contract between CMS and The Health Plan to offer Medicare Plans or the completion of any audit, as described in your contract with The Health Plan. As an authorized representative from your organization, you are required to complete The Health Plan s First Tier Compliance Attestation on behalf of your organization on an annual basis to attest to your compliance with CMS Compliance Program requirements. An authorized representative is an individual who has responsibility directly or indirectly for all employees, contracted personnel, providers/practitioners, and vendors who provide health care and/or administrative services for The Health Plan s Medicare Plans, such as your compliance officer, chief medical officer, practice manager/administrator, provider, executive officer or similar related positions. Descriptions of each CMS Compliance Program requirements are as follows: A. Fraud, Waste and Abuse (FWA) Training and General Compliance Training and Code of Conduct/Compliance Policy Distribution. As a first tier entity you or your organization are required to provide FWA training to all your employees and downstream entities that provide administrative and/or health care services for The Health Plan s Medicare lines of business. To comply with this requirement, we provide The Health 10

11 Plan Compliance and FWA prevention training for your use. The training must be completed within 90 days of the initial hire or the effective date of contracting and at least annually thereafter. You are required to maintain evidence of training; this may be in the form of attestations, training logs or other means determined by you to best represent completion of your obligations. Other options are: CMS Fraud Waste and Abuse training: Network-MLN/MLNProducts/ProviderCompliance.html; Another FWA training which meets CMS requirements outlined in 42 CFR (b)(4)(vi)(C) and 42 CFR (b)(4)(vi)(C) or CMS deemed FWA training through enrollment into Parts A or B of the Medicare program or accreditation durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). Your organization must also provide The Health Plan s Code of Conduct (COC) or your equivalent COC/compliance policies (collectively, Standards of Conduct ) to all employees and downstream entities who provide administrative or health care services for our Medicare lines of business. The Standards of Conduct must be distributed within 90 days of hire or the effective date of contracting, and any updates to Standards of Conduct and annually thereafter. Evidence of distribution of the Standards of Conduct must be maintained in a manner that best represents completion of your obligation. Standard of Conduct requirements can be found in 42 C.F.R (b))4)(vi)(a) for Medicare Advantage and 42 C.F.R. (b)(4)(vi)(a) for Part D, further described in CMS Managed Care Manual, Chapter 21 Section Compliance Program Guidelines and CMS Prescription Drug Benefit Manual, Chapter 9-Compliance Program Guidelines released by CMS effective January 11, B. Exclusion List Screenings Federal law prohibits the payment by Medicare, Medicaid or any other federal health care program for an item or service furnished by a person or entity excluded from participation in these federal programs. The Health Plan and its FDRs are thereby prohibited from contracting with or doing business with any person or entity that has been excluded from participation in these federal programs. Prior to hire and/or contract, and monthly thereafter, each first tier entity must perform a check to confirm its employees and downstream entities performing administrative or health care services for The Health Plan s Medicare lines of business are 11

12 not excluded from participation in federally-funded health care programs according to the OIG, SAM exclusion list screening. Office of Inspector General (OIG) list of excluded individuals and entities: General Services Administration (GSA) Systems for Award Management (SAM): In the event any of your employees or downstream entities are found on either of these exclusion lists you are to immediately remove the individual/entity from the work related directly or indirectly to The Health Plan s Medicare Program and notify The Health Plan of your findings. You must maintain evidence of checks of these exclusion lists (i.e., logs or other records) to document that each employee and downstream entity has been queried through the exclusion list in accordance with current laws, regulations and CMS requirements. The reason The Health Plan is requiring you and your downstream entity check these exclusion lists rather than conducting verifications ourselves; as an MA organization and Part D sponsor we are required to ensure that these exclusion lists are checked prior to hiring or contracting of any new employee or temporary employee. Volunteers, consultants, governing body members, and first tier and related entities; The Health Plan cannot ensure we know on a timely basis the identity of all your employees and downstream entities. To ensure timely compliance with CMS requirement, all of our first tier entities must confirm their permanent and temporary employees and volunteers who provide administrative and health care services for our Medicare lines of business are not on either exclusion list. Exclusion list requirements can be found in 1662(e)(1)(B) of the Social Security Act, 42 C.F.R (b)(4)(vi)(f), (a)(8), ,(b)(4)(vi)(F), (a)(6), , further explanation can found in CMS Managed Care Manual, Chapter 21-Compliance Program Guidelines, Section and also in Chapter 9-Compliance Program Guidelines and CMS Prescription Drug Benefit Manual released by CMS, January 11, C. Reporting FWA and Compliance Issues or Concerns to The Health Plan 12

13 The Health Plan is committed to the prevention, detection and correction of incidents that could lead to fraudulent, abusive or wasteful behavior. With that commitment, The Health Plan also holds that it is the duty of every person who has knowledge or a good faith belief of a potential compliance or issue of fraud, waste or abuse to promptly report such an issue or concern upon discovery. This reporting obligation applies even if the individual with the information is not in a position to mitigate or resolve the potential problem. This applies to all of The Health Plan s FDRs. There are various reporting mechanisms for use in confidentially reporting any compliance concern or suspected or actual misconduct for FWA: The Health Plan s Fraud Hotline at , as listed in The Health Plan s reporting mechanism poster found on The Health Plan s website. You may use this poster for distribution within your organization or your downstream entities or retain it as a reference tool and custom design your own internal poster for reporting and collecting these issues which then should be reported to The Health Plan. The reporting can be made anonymously. The Health Plan s Fraud Suspect Activity Form, which can be completed and submitted online at Submission by mail to, The Health Plan, National Road East, St. Clairsville, OH 43950: Attn: SIU Department. ***Incidents of FWA or compliance issues can be reported anonymously, however it must be noted that any anonymous reports of suspicious behavior can hinder or otherwise delay the Health Plan s ability to investigate and act upon the reported issue. The Health Plan has also adopted, and all FDR entities of The Health Plan are urged to adopt and enforce a zero tolerance policy for intimidation or retaliation against anyone who reports suspected or actual misconduct. D. Offshore Operations and CMS Reporting To ensure compliance with applicable federal and state laws, rules and regulations, you are prohibited from using any offshore individual or entity, including, but not limited to, any employee, contractor, downstream (subcontractor), agent, representative or other individual or entity, to perform any services for The Health Plan Medicare lines of business if the individual or entity is physically located outside of the United States territories unless an authorized Health Plan representative agrees in advanced and in writing to the use of such offshore entity (i.e., American Samoa, Guam, Northern Marianas, Puerto Rico and Virgin Islands). 13

14 Should you engage or utilize an offshore entity to perform services for our Medicare lines of business in an offshore location involving the receipt, processing, transferring, handling, storing or accessing a Medicare member s protected health information (PHI) and this arrangement was approved by The Health Plan, an attestation must be submitted to CMS notifying them of your use of the offshore entity. An example provided by CMS of offshore services that could cause this attestation requirement is offshore subcontractors that receive radiographic images for reading, because the Medicare beneficiary PHI is included with the radiographic image and the diagnosis is transmitted back to the U.S. You are required to notify your Health Plan representative immediately if you intend to use an offshore entity to perform services for our Medicare members. E. Monitoring and Auditing of First Tier and Downstream Entities CMS requires The Health Plan to develop a process to monitor and audit our first tier entities to ensure compliance with all applicable laws and regulations, and to ensure our first tier entities are monitoring the compliance of their downstream entities. If you choose to subcontract, with other individuals/parties to provide administrative and/or health care services for The Health Plan s Medicare lines of business, you are required to ensure these downstream entities comply with all laws and regulations that apply to first tier entities, including Chapters 9/21 of the Medicare Compliance Program requirements. You or your organization are required to conduct sufficient oversight to test and ensure your employees and downstream entities are compliant with applicable law and retain evidence of completion, and implement corrective action plans or take disciplinary actions, as necessary to prevent recurrence of noncompliance with applicable law. The Health Plan will incorporate this annual monitoring during our annual delegation audit of first tier entities to provide oversight and ensure compliant administration of our contracts with CMS to offer Medicare Plans as well as applicable laws and regulations. The first tier entity must cooperate fully and participate in these monitoring and auditing activities conducted by The Health Plan s Compliance or Internal Audit Staff, or those conducted by federal, state and local government agencies as needed. If a first tier entity performs their own audits, The Health Plan may request the audit results. First tier entities are encouraged and expected to routinely monitor and periodically audit their downstream entities. 14

15 If it is determined an FDR is not compliant with any of the requirements contained in the FDR Compliance Guideline, the FDR will be required to develop and submit a Corrective Action Plan (CAP). The Health Plan will provide assistance to the FDR in addressing any compliance issues identified. Monitoring and auditing requirements are contained in 42 C.F.R (b)(4)(vi)(f) for Medicare Advantage and 42 C.F.R. 423,504 (b)(4)(vi)(f) for Part D as described in CMS Medicare Manual, Chapter 21,- Compliance Program Guidelines Section and CMS Prescription Drug Benefit Manual, Chapter 9-Compliance Program Guidelines released by CMS, effective January 11, V. Violations of These Standards of Conduct Suspected violations of these Standards of Conduct must be reported to The Health Plan immediately. Any individual who makes a report in good faith will not be subject to retaliation or any other form of reprisal. The Health Plan will make every effort to protect the rights of any individual accused of violating these Standards of Conduct. However, any person who deliberately makes a false accusation with the intention of harming or retaliating against another person or The Health Plan will be subject to disciplinary action. The Health Plan will impose disciplinary actions for violations of law, CMS regulations, non-compliance with the Medicare program, and FWA. These actions may include, but are not limited to, oral or written warnings, suspensions, financial penalties, and/or reporting of the conduct to the appropriate law enforcement agency, and/or contract termination. VI. Required Attestations: 1. Standards of Conduct, Compliance Policies and Compliance Information My organization has established and publicized compliance policies, Standards of Conduct, and compliance reference material that meet the requirements set forth by CMS in 42 CFR (b)(4)(vi)(A) and 42 CFR (b)(4)(vi)(A). This information is disseminated to employees and contractors upon hire and annually thereafter. A record of all employees and contractors receipt of the policies, Standards of Conduct, and information is maintained for a period of ten years and can be provided upon request. 15

16 The compliance policies and/or Standards of Conduct reflect a commitment to preventing, detecting, and correcting noncompliance. The compliance reference material includes, at minimum, information on the Deficit Reduction Act of 2005 and the False Claims Act. OR My organization does not have established compliance policies and/or Standards of Conduct. The Health Plan Compliance FDR and Affiliate Guide have been disseminated to all employees and contractors. It includes: The Health Plan Compliance Code of Conduct, compliance policies, and information on select regulations, including but not limited to, the Deficit Reduction Act of 2005 and the False Claims Act. A record of all employees and contractors receipt of the Health Plan Compliance FDR and Affiliate Guide will be maintained for a period of ten years and can be provided upon request. 2. Fraud, Waste and Abuse Training My organization has fulfilled the FWA training requirement via the CMS FWA training. All employees and contractors have completed this FWA training within 90 days of hire/contract and annually thereafter. The CMS FWA training can be accessed at Learning-Network-MLN/MLNProducts/Downloads/Fraud- Waste_Abuse-Training_12_13_11.zip OR My organization has fulfilled the FWA training requirement via another FWA training that meets or exceeds the requirements as outlined by CMS in 42 CFR (b)(4)(vi)(C) and 42 CFR (b)(4)(vi)(C). All employees and contractors have completed this FWA training within 90 days of hire/contract and annually thereafter. OR My organization is "deemed" to have met the FWA training requirement through enrollment into Parts A or B of the Medicare program or through 16

17 accreditation as the supplier of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). 3. OIG and GSA Exclusion Screening My organization currently performs exclusion screening prior to hire and/or contract and monthly thereafter to confirm that employees and contractors are not are excluded to participate in federally-funded health care programs according to the OIG and GSA exclusion lists. If an employee or contractor is on an exclusion list he or she shall be removed from any work related directly or indirectly to federal health care programs and appropriate corrective action will be taken. OR My organization does not currently perform exclusion screening prior to hire and/or contract and monthly thereafter. Within 60 days of receipt of this form, and monthly thereafter, a check will be done to confirm that employees and contractors are not are excluded to participate in federally-funded health care programs according to the OIG and GSA exclusion lists. If an employee or contractor is on an exclusion list he or she will be removed from any work related directly or indirectly to federal health care programs and appropriate correction action will be taken. 4. Fraud, Waste and Abuse and Compliance Issues Reporting Mechanisms My organization maintains a confidential FWA and compliance reporting mechanism. It has been distributed and widely publicized for all employees and contractors within the organization to encourage reporting potential FWA and compliance issues. OR My organization does not maintain a confidential FWA and compliance reporting mechanism. The Health Plan FWA and Compliance Confidential Hotline ( ) and website (healthplan.org) have been distributed and widely publicized for all employees and contractors within our organization to encourage reporting potential FWA and compliance issues. 17

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