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Medicare’s Requirements for First Tier, Downstream & Related Entities 

First Tier, Downstream and Related Entities, also known as FDRs, are expected to comply with all Centers for Medicare & Medicaid Services regulatory requirements for their delegated functions. If you are contracted with Samaritan Health Plans to provide administrative and/or health care services for our Medicare Advantage and/or Medicare prescription drug products (collectively, “Medicare products”), you are a “first tier entity,” as defined by CMS.  As a first-tier entity, you must comply with the CMS Medicare Compliance Program requirements.

The FDR Compliance FAQs below provide a summary of the Medicare Compliance Program requirements. These requirements apply to you/your organization as a first-tier entity, any of your downstream entities and/or your individual employees who are assigned to perform services for our health plan.

CMS (FDR) Requirements FAQs

a) The FDR has a process in place to confirm its employees, contractors, board members, or any shareholders (interest of 5% or more) that work directly or indirectly on any federal health care program do not appear in the List of Excluded Individuals/Entities as published by the Department of Health and Human Services Office of the Inspector General, nor in the List of Debarred Contractors as published by the General Services Administration.

b) The FDR, its employees, board members, agents and contractors that provide administrative services or health care services for or to Medicare Advantage members, participate in Medicare fraud, waste and abuse (FWA) training that meets CMS requirements.

c) The FDR agrees to comply with SHPO Group (SHPO) conflict of interest policy or a conflict of interest policy developed by FDR that meets CMS requirements.

d) The FDR agrees to comply with SHPO’s Code of Business Conduct (COBC) and the COBC Guide (which includes SHPO’s disciplinary standards) and policies and procedures, or to adopt and comply with its own code of conduct, disciplinary standards and policies and procedures that reflect a commitment to detecting, preventing and correcting non-compliance with Medicare requirements in the delivery of Medicare services, including detecting, preventing and correcting fraud, waste and abuse.

e) The FDR is required to publish disciplinary standards which include its expectation that employees ask Medicare compliance questions and report potential and actual instances of non-compliance with Medicare requirements to SHPO through its anonymous hotline or through other means. Disciplinary standards must also state that any violation of these standards will result in appropriate disciplinary action, up to and including termination of employment. They also must include a non-retaliation policy for good-faith reporting.

f) The FDR will report compliance or FWA concerns and will publicize to its employees the methods for reporting potential and actual instances of Medicare fraud, waste and abuse to SHPO through its anonymous hotline or through other means. Federal law prohibits SHPO from retaliating against FDRs or their employees for reporting a fraud, waste and abuse issue.

2. What actions do FDRs need to perform to be in compliance with the FDR requirements?

a) FDRs will check the federal exclusion lists prior to hire and monthly thereafter.

b) If an employee, contractor, board member or shareholder (interest of 5% or more) is on either exclusion list, the FDR shall immediately remove the person or entity from any work related directly or indirectly to all federal health care programs and will take appropriate corrective actions, including preventing payment to excluded entity. The FDR will notify SHPO of the finding and action.

c) CMS FWA training will be conducted within ninety (90) days of hire and annually thereafter and there will be documentation attesting to the completion of this annually. Please note that you must use either the free CMS online FWA training or SHPO FWA training to meet this requirement.

d) The FDR will contact the Medicare hotlines with compliance questions and to report potential and actual instances of non-compliance.

e) Standards of Conduct and policies and procedures will be distributed to all employees who provide administrative services or health care services for SHPO’s Medicare Advantage program at time of hire and annually thereafter.

f) Conflict of interest disclosure forms will be distributed at time of hire and annually thereafter to governing body, officers and senior leadership, as applicable, certifying that they are free from any conflict of interest related to Medicare.

g) Disciplinary standards must be publicized and include:

  • Requirement to ask compliance questions and report potential and actual instances of noncompliance and Medicare FWA 
  • Violation of standards will result in appropriate disciplinary action up to and including termination 
  • Non-retaliation policy
No, FDRs may use a compliance program that meets CMS requirements as long as documentation is maintained.
No, FDRs are required to use only CMS FWA training, SHPO FWA training or FWA training provided by another Medicare Advantage and Part D Sponsor.

a) The FDR will keep a record that confirms reviews of the two federal exclusion lists have been completed. This generally includes a copy of each exclusion list with confirmations for initial hires and monthly verifications thereafter, along with employee names and verification dates.

b) A copy of fraud, waste and abuse training materials will be maintained and proof that such training has been completed by its employees, board members, agents and contractors (e.g. attestations). FWA training must be provided by CMS, SHPO or another Medicare Advantage and Part D Sponsor.

c) Copies of conflict of interest certifications for governing body, officers, and senior leadership, as applicable, directly or indirectly with the federal health care program will be maintained and made available for audit purposes.

d) Copies of Standards of Conduct attestations will be maintained and made available for audit purposes.

e) Copies of compliance program policies and procedures, including non-retaliation policy and disciplinary standards will be reviewed.

FDRs may be asked to provide documentation that demonstrates compliance with the FDR requirements.

Required for First Tier, Downstream, and Related Entities (FDRs)

Starting Jan. 1, 2016, to comply with training requirements, sponsors must accept from FDRs certificates of completion of CMS’ training located on the Medicare Learning Network.

CMS Update Compliance Program Training Memo

The Centers for Medicare & Medicaid Services, also known as CMS, requires First Tier, Downstream, and Related Entities (FDRs) employees to complete its Medicare Fraud, Waste, and Abuse  training within 90 days of hire and annually thereafter. Required FWA training is developed and provided by CMS and is available through the CMS Medicare Learning Network. CMS has provided two training modules to fulfill this requirement:

  • Medicare Parts C and D General Compliance Training.
  • Combating Medicare Parts C and D Fraud, Waste and Abuse Training.

Once an individual completes the training, the system will generate a certificate of completion. Copies of your completed training attendance logs and completion certificates must be made available for audit upon request by Samaritan Health Plans or CMS.

Integrity Program and Disciplinary Standards

Samaritan Health Plans strives to ensure compliance with federal, state and local laws and regulations that apply to the health insurance industry and to each contract. We are committed to comprehensive compliance with contractual, legal, and ethical expectations. Our policies and procedures reflect the organization’s goal to meet or exceed compliance standards. The Centers for Medicare & Medicaid Services expects us to share our standards of conduct with our FDRs and either ensure that these entities adhere to our standards or ensure that these entities adopt and follow their own standards of conduct. These standards reflect a commitment to detecting, preventing and correcting noncompliance with regulatory requirements, including detecting, preventing and correcting fraud, waste and abuse.

Corporate Integrity Program
Samaritan Health Plans’ Disciplinary Standards

Disclosure and Attestation

The Centers for Medicare & Medicaid Services expects Samaritan Health Plans to regularly audit conflict of interest attestation from our First Tier, Downstream, and Related Entities, also known as FDRs. We require annual completion of these certifications because it ensures that each FDR has effectively screened managers, officers and directors responsible for the administration or delivery of Medicare Advantage and Part D benefits. An annual or upon hire signed conflict of interest statement attests that the manager, officer or director is free from any conflict of interest in administering or delivering these benefits. Conflicts must be reported to our Compliance Department immediately upon discovery.

Conflict of Interest Policy
Conflict of Interest Attestation

Review Exclusion Databases Pre- and Post-Hire

All First Tier, Downstream, and Related Entities must review the exclusion databases listed below prior to hire and monthly thereafter for current employees, officers and directors, board members, subcontractors, consultants and vendors, as applicable. You must notify the Samaritan Health Plan Operations’ Compliance Department immediately if an exclusion is identified. Excluded persons or entities are prohibited from receiving payment.

OIG Exclusion list
GSA Exclusion list

Exclusion logs that include employee’s name, date each database was checked and whether or not an exclusion was found must be made available for review, upon request.

Report Directly to Samaritan Health Plans

Members who indicate dissatisfaction to you or your employee regarding any aspect of their experience must be immediately directed to the health plan. If you are dealing directly with our members and receive a grievance and/or appeal request, send the member’s name, member ID, date, time of contact and description of issue to Samaritan Health Plans:

Questions: Corvallis 541-768-4550, toll free 800-832-4580, Monday through Friday, 8 a.m. to 6 p.m.

Fax request to: 541-768-9765

Mail request to:  SHP Appeals Team, PO Box 1310, Corvallis, OR 97339

Help Us Detect, Prevent, and Correct

Samaritan Health Plans is committed to ethical business practices; complying with all Medicare requirements; and detecting, preventing and correcting fraud, waste and abuse. If you have concerns about ethics, compliance, or fraud, please consult the following resources. Samaritan Health Plans has a zero-tolerance policy for retaliation or retribution against any employee, affiliate, or related entity who, in good faith, reports suspected misconduct or fraud, waste and abuse.

If you suspect fraud, waste or abuse, please report it immediately through any of the following channels:

Visit our Fraud, Waste and Abuse page for additional methods of reporting.

Confirm Your Compliance

Please review the FDR Compliance FAQs and confirm that you have internal processes to support your compliance with all of these Medicare Compliance Program requirements. These requirements include, but are not limited to, completion of the required initial Fraud, Waste and Abuse training within 90 days of hire/contracting. You are required to maintain evidence of your compliance with these Medicare Compliance Program requirements (e.g., employee and downstream entity employee training records, Centers for Medicare & Medicaid Services (CMS) certificate of completion, etc.) for the longer of:
1. 10 years from the final term of a contract between CMS and Samaritan Health Plans to offer one or more Medicare products, or;
2. The completion of any audit, as further described in your contract with us.

For monitoring and auditing purposes, Samaritan Health Plans and/or CMS may request that you provide evidence of your compliance with these requirements. We may pursue remedies available under our contract with you if you do not comply with the Compliance Program requirements. These remedies will vary depending on the extent of your non-compliance and may include requiring that you implement a corrective action plan, termination of services you provide for us and/or contract termination.

An authorized representative from your organization is required to complete the Compliance Attestation (on behalf of your organization) on an annual basis to attest to your organization’s awareness, completion and compliance with these Medicare Compliance Program requirements.