First-Tier, Downstream and Related Entities (FDR) - Dean Health Plan

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First-Tier, Downstream and Related Entities (FDRs)
CMS Compliance Program Requirements

1. Introduction — Dean Health Plan's Medicare Compliance Program

Dean Health Plan (Dean) has contracts with the Centers for Medicare and Medicaid Services (CMS) to administer Medicare benefits to Medicare beneficiaries. Dean delegates some of the administrative and health care services it is required to perform under these contracts to external entities. CMS refers to these entities as First Tier, Downstream and Related Entities (FDRs). CMS requires that FDRs comply with certain Medicare compliance program requirements — some of which are summarized below.

2. What is an FDR?

Dean defines FDRs according to CMS current definitions:

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 provide administrative services or healthcare services to a Medicare eligible individual under the Medicare Advantage program or Part D program.

Downstream Entity is any 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. These written arrangements continue down to the level of the ultimate provider of both health and administrative services.

Related Entity is any party that is related to a Medicare Advantage Organization or Part D sponsor by common ownership or control and: a) performs some of the Medicare Advantage Organization or Part D plan Sponsor’s management functions under contract or delegation; b) furnishes services to Medicare enrollees under an oral or written agreement; or c) leases real property or sells materials to the Medicare Advantage Organization or Part D plan Sponsor at a cost of more than $2,500 during a contract period.

3. FDR Compliance Program and Attestation Requirements

Dean obtains an annual attestation from its First Tier Entities to ensure its FDRs are in compliance with applicable compliance program requirements. An authorized individual from each First Tier Entity must attest that its organization and any of its Downstream and/or Related Entities are in compliance with requirements relating to the following:

  • Code of conduct and compliance policies
  • CMS’ fraud waste and abuse (FWA) and general compliance training
  • OIG/GSA exclusion screenings
  • Reporting non-compliance and FWA
  • Offshore operations
  • Auditing and monitoring
  • Maintenance of documentation to support the attestation for at least 10 years

Each year, Dean notifies FDRs via email of the deadline to submit the annual attestation and the availability of the attestation on this site. Dean may accept an FDR-created attestation as long as the attestation is sufficiently similar to Dean’s attestation.

Dean also conducts routine auditing and monitoring of its First Tier Entities to further ensure their compliance. FDRs are required to cooperate and participate in these activities, which may, for example, require the First Tier Entity to produce evidence that supports the attestation.

If Dean’s FDRs fail to submit a satisfactory attestation by the deadline or fail to satisfy any Medicare compliance program requirements, such failures may lead to a corrective action plan or other contractual remedies (e.g., contract termination).

a. FWA and General Compliance Training

First Tier Entities must ensure its employees and Downstream Entities complete general compliance and FWA training. The training requirements are summarized below. For additional information, refer to CMS’ recent HPMS memos:

    • Additional Guidance – Compliance Program Training Requirements and Audit Process Update (Dec. 29, 2015)
    • Update – Reducing the Burden of the Compliance Program Training Requirements (June 17, 2015)
i. Training timing

Training must be completed within 90 days of initial contracting/hiring and annually thereafter.

ii. Training methods

FDRs have three options for completing the training:

        • Complete the general compliance and/or FWA training modules located on the CMS MLN. Once an individual completes the training, the system will generate a certificate of completion.
          - To take this training, you need to create an account at https://learner.mlnlms.com.
          - At the “Organization” field, click on “Select”. On the “Select Organizations” screen, leave the “Find Organization” field blank and click on “Search”. Select ‘CMS-MLN Learners Domain - Organization’ and click on “Save”.
        • Once you are logged in, you can find the appropriate trainings by entering the following titles into the search bar:
          - Medicare Parts C and D General Compliance Training
          - Combating Medicare Parts C and D Fraud, Waste and Abuse

        • Download and incorporate the content of the CMS standardized training modules from the CMS website into their organizations’ existing compliance training materials/systems.
        • Incorporate the content of the CMS training modules into written documents for providers (e.g. Provider Guides, Participation Manuals, Business Associate Agreements, etc.).

The training content cannot be modified, except with respect to its appearance (i.e. font, color, background, format, etc.).

iii. Training applicability

The entire staff is not necessarily subject to the requirement. CMS has provided “examples of the critical roles within an FDR that should clearly be required to fulfill the training requirements”:

        • Senior administrators or managers directly responsible for the FDR’s contract with the Sponsor (e.g. Senior Vice President, Departmental Managers, Chief Medical or Pharmacy Officer);
        • Individuals directly involved with establishing and administering the Sponsor’s formulary and/or medical benefits coverage policies and procedures;
        • Individuals involved with decision-making authority on behalf of the Sponsor (e.g. clinical decisions, coverage determinations, appeals and grievances, enrollment/disenrollment functions, processing of pharmacy or medical claims);
        • Reviewers of beneficiary claims and services submitted for payment; or,
        • Individuals with job functions that place the FDR in a position to commit significant noncompliance with CMS program requirements or health care FWA.

If you have questions about which employee positions within your organization should be required to take the training, please contact Dean at DHP.FDRoversight@deancare.com.

The only exception to the training requirement is that FDRs are deemed to have met the FWA training requirements through enrollment into the Medicare program or accreditation as a supplier of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). Such parties are still required to complete the general compliance training requirement.

b. Code of Conduct and Compliance Program Policy Distribution

First Tier Entities must provide either Dean’s Code of Conduct and compliance policies or its own comparable code of Conduct and compliance policies to all employees and Downstream Entities who provide administrative or healthcare services to Dean’s Medicare plans. If you wish to distribute your own documents, you must email the documents to DHP.FDRoversight@deancare.com so Dean can determine whether it considers the documents comparable to Dean’s.

These documents must be distributed:

    • within 90 days of hire or the date of contracting,
    • when updates are made, and
    • annually thereafter.

c. Exclusion List Screenings

Federal law prohibits Medicare, Medicaid and other federal health care programs from paying for items or services provided by an individual or entity excluded from participation in these federal programs. Therefore, before hiring or contracting, and monthly thereafter, each FDR must check exclusion lists from the Office of Inspector General (“OIG”) and General Services Administration (“GSA”). The exclusion lists are located at the following websites:

If an FDR discovers an employee or Downstream Entity on one of these exclusion lists, it must immediately remove the employee or Downstream Entity from work directly or indirectly related to Dean’s Medicare Plans and send an email notification to DHP.FDRoversight@deancare.com.

d. Reporting FWA and Compliance Issues to Dean

If any FDR or FDR employee knows of, or suspects, an issue of noncompliance or FWA, they are required to report the incident to Dean within two business days of discovery. Reports should be made by either:

    • Emailing Dean’s Vendor Non-Compliant Incident Reporting Form to DHP.FDRoversight@deancare.com, or
    • Calling Dean’s 24/7 Anonymous Compliance Hotline at (877) 317-0255
    • Writing Dean Health Plan, ATTN: Compliance Department, 1277 Deming Way, Madison, WI 53717

Dean encourages its FDRs to publicize this reporting requirement throughout their facilities and has created a poster for their convenience.

e. Monitoring and Auditing

A First Tier Entity is expected to have monitoring and auditing procedures in place to ensure it is in compliance with all applicable laws and regulations. Also, if a First Tier Entity subcontracts with other individuals or entities to provide administrative and/or health services, it is responsible for monitoring and auditing these Downstream Entities to ensure they comply with all laws and regulations that apply to the First Tier Entity.

If you have questions or concerns about any of these requirements, contact Dean’s Medicare Compliance Team at DHP.FDRoversight@deancare.com or Dean’s Medicare Compliance Officer at Laura.LeCaptain@deancare.com.

DHP-WE079D

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