Delegate Oversight: FDR Regulations and Oversight Expectations February 2015 Delegated Entity...

Delegate Oversight: FDR Regulations and Oversight ExpectationsFebruary 2015

Delegated Entity Oversight Program

2Proprietary Information of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group.

First Tier, Downstream & Related Entities (FDR) Requirements

• Reference: • Medicare Advantage: 42 CFR 422.503(b)(4)(vi)(C) • Part D 42 CFR 423.504(b)(4)(vi)(C) • Chapter 9 (Part D) and Chapter 21 (Medicare Advantage)

• Three Key elements for Delegate Oversight:1. Code of Conduct Policy Awareness & Attestation;2. Fraud, Waste and Abuse (FWA) & Compliance Training; 3. Exclusion/ Sanction/ Debarment Checks

• Code of Conduct and FWA/Compliance training requirements must be completed within 90 days of hire for all new employees and Annually thereafter.

• OIG & GSA Exclusions checks must be completed prior to hire and monthly thereafter.


Compliance / FWA Training

• FWA Training must include, at a minimum, the following:

• Laws and regulations related to MA and Part D FWA• Example: False Claims Act, Anti-Kickback Statue, HIPAA

etc…• Compliance Policies – Conflict of Interest, Non-Retaliation• Reporting Mechanisms• Employee Requirements – training, reporting misconduct• Disciplinary Guidelines• Types of potential non-compliance and/or FWA that can occur in

the settings in which employees work

For 2016, CMS requires that all FDRs use the CMS-provided FWA training through the Medicare Learning Network.

FDR Oversight Documentation

FWA/Compliance Training:• Sign-in sheet indicating employee name, date of training,

place/method of training, employee signature.• If training is done individually via on-line method such as WebEx, an

electronic signature &/or log-in report is acceptable• If the individual completes the FWA/Compliance training by reviewing

the information individually via electronic methods, a printable attestation sheet or electronic signature that can be stored and archived Is required.

• Certification page from each module printed/screen printed, if using Medicare Learning Network module

Code of Conduct:• All employees must review the UHG Code of Conduct or one created

by your organization that meets all CMS requirements as outlined in Ch 9/21

• Required within 90 days of hire and annually thereafter



Sanction/Exclusion/Debarment Checks

All employees must be in good standing with the Federal health care programs. •FDRs contracted with UnitedHealthcare Medicare Advantage, Part D or UnitedHealthcare Community Plan must review the federal exclusion lists (DHHS-OIG List of Excluded Individuals and Entities) and GSA Excluded Parties List System (EPLS) at System for Award Management prior to hiring or contracting to ensure that none of these persons or entities are excluded from participation in federal programs

•This includes employees (including temporary workers and volunteers), the CEO, senior administrators or managers, governing body members, and sub-delegates who have involvement in the administration or delivery of UnitedHealthcare Medicare Advantage, Part D benefits or services and/or UnitedHealthcare Community Plan services.

•FDRs must continue to review the federal exclusion lists on a monthly basis thereafter. FDRs contracted to provide services to UnitedHealthcare Community Plan may be subject to state-based exclusion lists as well.

* See resources on final page of presentation for links to OIG/GSA

Documentation of FDR Oversight

• Documentation supporting completion of the OIG and GSA exclusion reviews may include the following:

• Screen prints of the page from the website stating that there is no match or if there is a name match, that the secondary verification did not produce a match,

• Download the databases and produce your own reports with all elements of the ‘Report Components’ bullet below included

• Online service that produces reports; Payroll service that sends you monthly reports to verify that the exclusion reviews have been done

• Report Components:The date the report was run,

When the database was last updated with revised LEIE or EPLS data

Your employee’s names listed either with “No Matches” or

If there are matches a list of all LEIE or EPLS names that match your employee’s name

The report should clearly state the rules used to match your employees’ names against the LEIE or EPLS data, i.e., match last name only, or match last name and first letter of first name, etc.

Finally, there would have to be screen prints of the results of secondary verifications on the LEIE or EPLS websites (SSN can be redacted) for any preliminary matches.


ResourcesExclusion Review Resources

OIG database can be downloaded from:http://oig.hhs.gov/exclusions/index.asp

GSA database can be downloaded from:https://www.sam.gov/portal/public/SAM/

UHG Code of Conduct document: •http://www.unitedhealthgroup.com/~/media/uhg/pdf/about/unh-code-of-conduct.ashx

FWA/Compliance Training:•FWA/Compliance training for current year is available under the Additional Learning section using the link below:https://www.unitedhealthcareonline.com/b2c/CmaAction.do?channelId=8c6592752e071110VgnVCM100000c520720a____

•Module link is located at the bottom of the page under the Compliance, Fraud, Waste and Abuse Training section•CMS modules are available through the www.CMS.gov website

CMS Guidance on FDR Oversight:Chapter 9 of the Prescription Drug Benefit Manualhttp://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/mc86c21.pdf

Chapter 21 of the Medicare Managed Care Manualhttp://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/mc86c21.pdf


http://oig.hhs.gov/exclusions/index.asp

https://www.sam.gov/portal/public/SAM/

http://www.unitedhealthgroup.com/~/media/uhg/pdf/about/unh-code-of-conduct.ashx

http://www.unitedhealthgroup.com/~/media/uhg/pdf/about/unh-code-of-conduct.ashx

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