Compliance Mgmt
Any potential or actual violations of compliance, safety, security, policy, and/or ethical behavior.
What is a compliance breach?
The metric (KPI) for live visits to a Top 20 account
What is twice a month?
May attend only the general, non-sales portions.
May not attend discussions related to sales messaging, sales directions, or sales strategies.
What is a sales meeting? (POA - Point of Action)
Patient-identifiable information created or received by a “Covered Entity”, including an HCP or Specialty Pharmacy as defined by the Health Insurance Portability and Accountability Act.
What is PHI (Patient Health Information)?
The goal of the Rules of Engagement (ROE) is to provide guidelines for engagement to the Field Reimbursement Managers (FRMs). FRMs activities are focused on providing _________ __________.
What is educational support?
Any untoward or undesirable medical occurrence in a patient linked in time with the use of a product.
What is an AE or “Adverse Event”?
When appropriate HIPPA authorization is on file, the FRM may ask if the HCP or HCPOS would like the FRM to reach out to the SP on behalf of the patient case. The FRM can reach out to ________ and ________.
What is the FRAS can discuss PHI with both national and local SP reps?
May attend only Access and/or Fulfillment Portion.
May only discuss payer trends or access and/or fulfillment issues affecting the region.
May not discuss single-patient cases or disclose patient-identifiable information.
What are district or regional sales team calls/meetings?
Must be in place for a FRM to handle or discuss PHI with HCPs or HCPOS.
What is a signed Business Associate Agreement (BAA) OR a signed Universal Patient Authorization form on file with the appropriate Janssen HUB?
Rosalind Flemming
Who is the DERM Janssen Business Lead?
Timeframe for reporting a compliance breach, issue or Adverse Event.
What is 24 hours / 1 day?
Approved email templates
What are communications that contain any mention of a Janssen product or Janssen service?
May attend the full program as an observer but must not participate in the discussion during the presentation itself or conduct calls with attendees at the external site. FRM should limit interactions to introductions and logistics.
What is a BC DOME program?
· Site Name, Site Contact Name and Title
· Contact Phone # and/or email
· Product
· Date of Breach
· Summary of Breach
· Action Taken re: Breach
What is required information to report a PHI compliance breach?
The requirement for a FRM to share a resource with a HCP or HCPOS.
What are Janssen Copy Approval Committee (“CAC”) approved materials?
They handle communication with patients
Who are Guides or Companions?
May be present at the venue prior to the start of the speaker program for introductions. Must leave the venue prior to the start of the promotional program or clinical discussion.
What is a clinical speaker program? (includes "fireside chats")
The one limited exception when a FRM may save PHI on their laptop, iPad or mobile device.
What is a "Janssen" provided iPad or laptop?
When can an Immunology FRM pay for an in-office meal with a HCP or HCPOS?
What is never? IMM FRMs are not allowed to provide any food to HCP/HCPOS.
Responsible party for reporting a compliance issue or Adverse Event.
Who is everyone / vendor partner employee or a Janssen employee? (Whoever receives the issue)
Per the ROE, the only situation in which case IDs can be communicated between JFSR/DMs and FRMs.
What is if an HCP or HCPOS mentions to a JFSR or District Manager that they are having issues with a certain case? (No other information that could lead to the identification of the patient, including but not limited to patient ID, may be shared.)
Requires approval from JBI business lead.
What is FRAS attendance at an external program?
The FRM cannot exchanged PHI via _________, _________ or __________ with any HCP offices, SPs, or Janssen sales reps.
What are email, text and voicemail?
There are two restrictions when can a FRM bill an alcoholic beverage:
What are after 5pm in your current time zone and there must be food on the bill totaling more than the beverage.