First-tier entity, downstream, and related entity (FDR)
If you or your organization contracts with Intermountain Healthcare for participation in one of our Medicare Advantage provider networks, you are considered a “first-tier entity, downstream, and related entity” (FDR) under the Centers for Medicare & Medicaid Services (CMS) guidelines.
Intermountain Healthcare provides a variety of resources to assist our contracted business partners, who are FDRs, to use in understanding the Medicare Advantage compliance requirements. Our commitment to compliance includes ensuring our FDRs also observe applicable laws, regulations, and sub-regulatory guidance.
Important FDR Definitions
- First Tier Entity: any party that enters into a written arrangement, acceptable to CMS, with an MAO or Part D plan sponsor or applicant to provide administrative services or healthcare services to a Medicare eligible individual under the MA program or Part D program.
- Downstream Entity: any party that enters into a written arrangement, acceptable to CMS, with persons or entities involved with the MA benefit or Part D benefit, below the level of the arrangement between an MAO 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: any entity that is related to an MAO or Part D sponsor by common ownership or control and:
- Performs some of the MAO or Part D plan sponsor’s management functions under contract or delegation;
- Furnishes services to Medicare enrollees under an oral or written agreement; or
- Leases real property or sells materials to the MAO or Part D plan sponsor at a cost of more than $2,500 during a contract period.
Medicare Advantage Regulations and Guidance
- CMS training materials
- Office of Inspector General’s List of Excluded Individuals and Entities (LEIE) includes all healthcare providers and suppliers that are excluded from participation in federal healthcare programs.
- System for Award Management (SAM) includes healthcare providers on the LEIE and includes other non-healthcare contractors that are excluded from federal programs.
- You can locate regulations governing the MA program at 42 CFR Part 422 and Part 423.
- CMS provides additional guidance for MA plans in the Medicare Managed Care Manual (Publication # 100-16) available through the CMS Internet-Only Manuals.
- CMS provides additional guidance for Prescription Drug Plans in the Medicare Prescription Drug Benefit Manual (Publication # 100-18) available through the CMS Internet-Only Manuals.
- CMS requires MA plans and their FDRs to check the Office of Inspector General and System for Award Management exclusion lists monthly to prevent inappropriate payment to providers, pharmacies, and other entities that have been excluded from participation in federal programs.
- MA plans are also required to check the Preclusion List monthly for providers who are precluded by CMS from receiving payment from a Medicare plan for healthcare items and services furnished to beneficiaries enrolled in the Medicare plan. Contracted MA plans are currently monitoring the Preclusion List.
Intermountain Healthcare providers and business partners (FDRs) are required to:
- Implement a compliance program that includes:
- Adoption of policies and procedures to prevent FWA, promote ethical conduct, and ensure compliance with Federal and State laws, regulations, and other requirements relating to the Medicare program
- A code of conduct
- Exclusion screening (Department of Health and Human Services Office of Inspector General [OIG] List of Excluded Entities and Individuals [LEIE] and the General Services Administration System for Award Management [SAM]
- Program for maintaining reporting and communication channels
- Downstream entities audit and monitoring for compliance with CMS requirements
- Ten-year records retention
- Annually train employees and contractors supporting contracted Medicare Advantage plans on compliance policies and FWA. Key parameters of recommended training include:
- FDRs no longer need to conduct training within 90 days of contract/hire; however, we suggest this timeframe as a best practice.
- The content of the training is at the discretion of your organization; however, it should incorporate the elements found in the compliance program guidelines outlined above under the first point.
- Download CMS training materials.
- Attest to compliance with Intermountain Healthcare requirements.
You are responsible for maintaining records of training completion and distribution of standards of conduct as proof of your organization’s compliance with Medicare requirements for a period of 10 years. Examples may include copies of sign-in sheets, employee attestations, and electronic certifications from the employees taking and completing the training.) Please be prepared to produce the required documentation as Intermountain Healthcare or CMS may request these materials at any time.
Standards of Conduct
Your organization’s standards of conduct must be distributed annually. If your organization does not have its own standards of conduct, share the Intermountain Healthcare Code of Ethics with your employees.