First Tier, Downstream, and Related Entities (FDR)



Medicare Compliance Program Self-Assessment Toolfor First Tier, Downstream and Related Entities (FDR)Objective: To confirm an organization’s compliance with the Medicare Compliance Program requirements. The requirements are described in detail within the FDR anization name: ________________________________________________________Date completed: _________________________Instructions: Review documentation and determine whether or not there is evidence to confirm the organization’s compliance with the listed requirements. Under “Documentation reviewed,” list the materials reviewed and applicable sections or page numbers that show compliance. Make notes in the section titled “comments.” Determine whether or not the documentation reviewed supports compliance with the requirement. Check “Met” if the documentation evidences compliance. Check “Not Met” if the documentation does not evidence compliance with the requirements. For any item listed as “Not Met,” complete a root cause analysis. Then develop a corrective action plan to address the root cause and bring your organization into compliance. Requirement“Employee” and “Downstream Entity” as used below, refer only to FDR employees and Downstream Entities that support Medicare products.MetNot MetCode of Conduct (“COC”) and/or Compliance PoliciesFDR provided Code of Conduct (COC) and/or Compliance Policies to applicable employees within 90 days of hire/annually/when changes are made. (§ 50.1.1 and 50.1.3) (Chapter 9 & 21)Method of Evaluation: Documentation, Policy, and Sample review. To meet this requirement, review the documentation for evidence that all of the following are met:Documentation ReviewDetermine if the FDR uses the CVS Code of Conduct, their own Code of Conduct or other compliance documents, such as a handbook or compliance policies and procedures. Note: if CVS Code of Conduct, content review is complete. - CVS Code of Conduct OR FDR's own COC or Compliance Policies:- If FDR COC, review the documentation provided to determine if the following content is included:??Policy ReviewA--the expectation of employees to act in an ethical and compliant manner. (50.1.1)??Policy ReviewB--the expectation that compliance is everyone’s responsibility from the top to the bottom of the organization. (50.1.1)??Policy ReviewC--the commitment to comply with all applicable Federal and State standards. (50.1)??Policy ReviewD-- Mechanisms for Reporting Compliance Concerns and Violations (50.4.2)??Policy ReviewE--the expectation for employees to report compliance concerns and potential violations (50.1.1, 50.4.2)??Policy ReviewF--the FDR's non-intimidation and non-retaliation policy for good faith reporting of compliance and FWA issues (50.1 and 50.4.2) ??Policy ReviewPolicy and Procedure (or other document) reflects new hire dissemination within 90 days of hire??Policy ReviewPolicy and Procedure (or other document) reflects dissemination at least annually and when material changes occur??Sample EvidenceDissemination occurred within 90 days of hire to all recently hired employees sampled (at least 10 employees but may vary based upon volume of new hires)??Sample EvidenceDissemination occurred annually to all sampled employees (at least 10 employees)??Reporting To Plan SponsorFDR reports compliance concerns and potential FWA which impact Medicare products to Plan Sponsor. (§ 50.4.2) (Chapter 9 & 21)Method of Evaluation: Policy and possible documentation review. To meet this requirement, review the documentation for evidence:Policy ReviewFDR uses Plan Sponsor’s reporting mechanisms OR has its own internal processes that include a mechanism for reporting back to Plan Sponsor.??Exclusion List Screenings: Office of Inspector General List of Excluded Individuals and Entities (“OIG”) and General Services Administration System for Award Management (“GSA SAM”)FDR screened employees against the OIG and GSA SAM exclusion lists prior to hire, validated any potential initial matches, and did not utilize positively matched individuals for Medicare products. (§ 50.6.8) (Chapter 9 & 21)Method of Evaluation: Policy, and Sample review. To meet this requirement, review the documentation for evidence that all of the following are met:Policy ReviewA--includes both OIG & GSA SAM??Policy ReviewB--both screenings are conducted prior to hire??Policy ReviewC--indicates appropriate actions if a match is identified (i.e. validate possible matches, decline applicant for Medicare functions)??Sample EvidenceOIG screenings were completed prior to hire for all recently hired employees sampled (at least 10 employees but may vary based upon volume of new hires)??Sample EvidenceGSA SAM screenings were completed prior to hire for all recently hired employees sampled (at least 10 employees but may vary based upon volume of new hires)??Sample EvidenceDocumentation included date screenings were completed??Sample EvidenceResults did not indicate any individual as a positive match on either list (i.e., excluded) to prohibit use with our Medicare products.??FDR screens applicable employees against the OIG and GSA SAM exclusion lists monthly, validated any potential matches, and immediately removed any positively matched individuals from the Medicare products. (§ 50.6.8) (Chapter 9 & 21)Method of Evaluation: Documentation, Policy, and Sample review. To meet this requirement, review the documentation for evidence that all of the following are met:Policy ReviewA--includes both OIG & GSA SAM??Policy ReviewB--both screenings are conducted monthly ??Policy ReviewC--indicates appropriate actions if a match is identified (i.e., validate possible matches, remove employee from Medicare functions) ??Sample EvidenceMonthly OIG screenings were completed on all employees sampled (at least 10 employees) for at least 3 consecutive months??Sample EvidenceMonthly GSA SAM screen were completed on all employees sampled (at least 10 employees) for at least 3 consecutive months??Sample EvidenceDocumentation included date screenings were completed??Sample EvidenceIf employee found to be excluded on either exclusion list, they were removed from supporting our Medicare business.??Downstream OversightEXEMPTION: Element #7 is Not Applicable (N/A) for FDRs without contracted Downstream Entities OR that do not use Downstream Entities for Medicare products.?Not Applicable (N/A): FDR declared that they do not use any subcontractors for Medicare products.FDR oversees the compliance of their subcontractors (i.e., Downstream Entities) whom they use for Medicare products which ensures: (a) Downstream Entities are compliant with Medicare regulations and requirements such as the Medicare Compliance Program Requirements as listed in above elements. [FDRs must make sure that their applicable Downstream Entities have the necessary education/information to be compliant.]; (b) Downstream Entities are meeting performance expectations; AND (c) Corrective actions for remediation of Downstream Entity deficiencies and disciplinary actions/ramifications (e.g., Downstream Entity contract term, etc.) for failure to satisfactorily remediate are enforced as appropriate. (§ 50.6.6, § 50.7.2) (Chapter 9 & 21)Method of Evaluation: Documentation and Policy review. If the entity has Downstream Entities that they use for Medicare products, review the documentation for evidence the FDR does monitoring OR auditing of their Downstream Entities to include all of the following:Policy ReviewPolicy and Procedure (or other document) reflecting their oversight processes AND??Documentation ReviewExamples of oversight program of Downstream Entities such as: Collection of FDR Attestations of compliance program requirements from a sample of their highest risk Downstream Entities; Audit of their highest risk Downstream Entities for compliance with compliance program requirements (Code of Conduct dissemination and reporting mechanism/obligations, OIG & GSA screenings, Downstream Entity oversight of their sub-contractors, etc.); AND??Documentation ReviewMechanisms are in place to apply corrective or disciplinary actions as appropriate.??Requirement“Employee” and “Downstream Entity” as used below, refer only to FDR employees and Downstream Entities that support Medicare products.MetNot MetFDR screens Downstream Entities against the OIG and GSA exclusion lists prior to contracting, validated any potential matches, and did not use or immediately removed any positively matched entities from the Medicare products. (§ 50.6.8) (Chapter 9 & 21)Method of Evaluation: Documentation, Policy, and Sample (Downstream Entity Examples) review. To meet this requirement, first determine if entity has subcontractors that they use for service delivery to the Medicare membership. If they have other Downstream Entities that they use for Medicare products, to meet this requirement review their documentation for evidence that all of the following are met:Policy ReviewPolicy and Procedure (or other document) reflects Exclusion List screenings (both OIG & GSA/SAM) of Downstream Entities prior to contracting, and appropriately listed actions that would be taken for any exclusion matches??Sample EvidencePrior to contracting OIG screenings were completed on Downstream Entity examples; AND??Sample EvidencePrior to contracting GSA SAM screenings were completed on Downstream Entity examples; AND??Sample EvidenceDocumentation included date screenings were completed; AND??Sample EvidenceIf Downstream Entity was found to be excluded on either exclusion list, they were removed from supporting Medicare business. ??FDR screens Downstream Entities against the OIG and GSA SAM exclusion lists monthly thereafter, validated any potential matches, and did not use or immediately removed any positively matched entities from the Medicare products. (§ 50.6.8) (Chapter 9 & 21)Method of Evaluation: Documentation, Policy, and Sample (Downstream Entity Examples) review. To meet this requirement, first determine if entity has subcontractors that they use for service delivery to the Medicare membership. If they have other Downstream Entities that they use for Medicare products, to meet this requirement review their documentation for evidence that all of the following are met:Policy ReviewPolicy and Procedure (or other document) reflects Exclusion List screenings (both OIG & GSA/SAM) of Downstream Entities monthly, and appropriately listed actions that would be taken for any exclusion matches??Sample EvidenceMonthly OIG screenings were completed on Downstream Entity examples for at least 3 consecutive months); AND??Sample EvidenceMonthly GSA SAM screenings were completed on Downstream Entity examples for at least 3 consecutive months); AND??Sample EvidenceDocumentation included date screenings were completed; AND??Sample EvidenceIf Downstream Entity was found to be excluded on either exclusion list, they were removed from supporting Medicare business. ?? ................
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