FDR Compliance Requirements and How To Meet Them

Reporting Mechanism For Compliance And FWA Issues

Requirements	How to Comply
Plan sponsors must have a system in place to receive, record, respond to, and track compliance questions or reports of suspected or detected noncompliance or potential FWA from employees, members of the governing body, enrollees, and FDRs and their employees. Reporting systems must maintain confidentiality (to the greatest extent possible), allow anonymity if desired (e.g., through telephone hotlines or mail drops), and emphasize the plan sponsor’s / FDR’s policy of non-intimidation and non-retaliation for good faith reporting of compliance concerns and participation in the compliance program. FDRs that partner with multiple plan sponsors may train their employees on the FDR’s reporting processes including emphasis that reports must be made to the appropriate PBM to forward to the appropriate plan sponsor. The methods available for reporting compliance or FWA concerns and the non-retaliation policy must be publicized throughout the sponsor’s or FDR’s facilities. Plan sponsors must make the reporting mechanisms user friendly, easy to access and navigate, and available 24 hours a day for employees, members of the governing body, and FDRs. It is a best practice for plan sponsors to establish more than one type of reporting mechanism to account for the different ways in which people prefer to communicate or feel comfortable communicating.(Medicare Prescription Drug Benefit Manual Ch. 9 §50.4.2)	Distribute the Navitus FDR Reporting Poster to your employees or post it in your facility. This will provide the required notifications regarding the availability of an anonymous reporting method and the Navitus policy prohibiting retaliation or retribution against anyone who reports suspected violations in good faith. This poster is available here. If you partner with multiple Medicare plan sponsors, train your employees on your organization’s reporting processes including an emphasis that reports must be made to the appropriate Medicare plan sponsor. Notify your employees that they are protected from retaliation for False Claims Act complaints. Below are suggested criteria for referring reported issues to Navitus. The list is not intended to be all inclusive. Any concerns about program noncompliance or suspected FWA should always be reported. Complaints or allegations that reference Navitus. Complaints from a Navitus member about quality of care received from a Navitus contracted provider or vendor. Complaints from Navitus members regarding access to care or services. Complainants wishing to appeal a Navitus coverage decision (medical or pharmacy) or to file a grievance about Navitus. HIPAA violations that impact Navitus members. Allegations that the complainant has been contacted by “someone” from Navitus requesting personal or medical information. Instances of alleged FWA. Instances where you become aware that an individual or entity involved with the Navitus has become excluded from participation in federal programs.

Requirements

How to Comply

Plan sponsors must have a system in place to receive, record, respond to, and track compliance questions or reports of suspected or detected noncompliance or potential FWA from employees, members of the governing body, enrollees, and FDRs and their employees. Reporting systems must maintain confidentiality (to the greatest extent possible), allow anonymity if desired (e.g., through telephone hotlines or mail drops), and emphasize the plan sponsor’s / FDR’s policy of non-intimidation and non-retaliation for good faith reporting of compliance concerns and participation in the compliance program. FDRs that partner with multiple plan sponsors may train their employees on the FDR’s reporting processes including emphasis that reports must be made to the appropriate PBM to forward to the appropriate plan sponsor.

The methods available for reporting compliance or FWA concerns and the non-retaliation policy must be publicized throughout the sponsor’s or FDR’s facilities. Plan sponsors must make the reporting mechanisms user friendly, easy to access and navigate, and available 24 hours a day for employees, members of the governing body, and FDRs. It is a best practice for plan sponsors to establish more than one type of reporting mechanism to account for the different ways in which people prefer to communicate or feel comfortable communicating.(Medicare Prescription Drug Benefit Manual Ch. 9 §50.4.2)

Distribute the Navitus FDR Reporting Poster to your employees or post it in your facility. This will provide the required notifications regarding the availability of an anonymous reporting method and the Navitus policy prohibiting retaliation or retribution against anyone who reports suspected violations in good faith. This poster is available here.
If you partner with multiple Medicare plan sponsors, train your employees on your organization’s reporting processes including an emphasis that reports must be made to the appropriate Medicare plan sponsor.
Notify your employees that they are protected from retaliation for False Claims Act complaints.
Below are suggested criteria for referring reported issues to Navitus. The list is not intended to be all inclusive. Any concerns about program noncompliance or suspected FWA should always be reported.
- Complaints or allegations that reference Navitus.
- Complaints from a Navitus member about quality of care received from a Navitus contracted provider or vendor.
- Complaints from Navitus members regarding access to care or services.
- Complainants wishing to appeal a Navitus coverage decision (medical or pharmacy) or to file a grievance about Navitus.
- HIPAA violations that impact Navitus members.
- Allegations that the complainant has been contacted by “someone” from Navitus requesting personal or medical information.
  - Instances of alleged FWA.
  - Instances where you become aware that an individual or entity involved with the Navitus has become excluded from participation in federal programs.