OIG and DOJ look at the same few things in a speaker program: the content, the audience, the meals and venue, and what the speaker is paid. Each pharma client’s SOP turns those concerns into rules, and each rule has a moment when it should be checked. This guide maps each concern to its rule and ends with ten questions to ask of any program record.
This guide is for the planners and compliance reviewers who run and check HCP speaker programs. It summarizes public sources. It is not legal advice and does not replace the client’s legal and compliance review.
What sets the rules
The Anti-Kickback Statute and False Claims Act are central to the public enforcement actions reviewed in the official sources. A recurring allegation is that payments and meals functioned as rewards for prescribing rather than education.
The HHS-OIG Special Fraud Alert from November 2020 described speaker-program characteristics that may indicate heightened fraud and abuse risk. CMS Open Payments is a separate public-reporting layer for applicable transfers of value. Each client’s compliance team turns these sources into its SOP. Sources: OIG and CMS.
The public enforcement context is also summarized in the official DOJ FY2025 source (DOJ) and in the 2025–26 case record.
Two more sources shape most client SOPs. The PhRMA Code, revised from January 1, 2022, tightened its guidance on meals, venues, and repeat attendance. DOJ’s September 2024 guidance on corporate compliance programs expects compliance teams to use data to manage risk, including risk from vendors.
What OIG looks for, and where the SOP checks it
Each concern below is paraphrased from OIG’s 2020 alert. The question is what to ask your own program team. The rule numbers link to the SOP map.
| OIG's concern | Question for the program team | Where the SOP checks it |
|---|---|---|
| Programs with little substantive content | Can the team show the approved deck, the trained speaker, and the rep's certification for every program? | |
| Meals beyond modest value, or alcohol | Is meal cost per attendee checked against the client's limit before close? | |
| Venues not suited to an educational program | Who approves the venue, and against which rule? | |
| Repeat programs on the same topic | Does anyone count programs per topic and territory before a request goes in? | |
| HCPs attending the same program again | Does the attendance limit apply on every path an HCP can come in by? Deep dive → | |
| Attendees without a reason to be there | Who checks that guests and trained speakers are not the audience? | |
| Speakers chosen for sales reasons | Who approves the speaker choice, and is the reason kept? | |
| Honoraria above fair market value | Is every honorarium tied to the speaker’s tier, contract, and annual cap? Speaker-fee benchmark → |
Source: HHS-OIG Special Fraud Alert: Speaker Programs (November 16, 2020).
Check each rule at the moment it applies
A rule checked at close-out is a rule found too late. Each stage has its own moment.
Request
Check the lead time when a date is picked, and the budget line when the request is submitted. Keep the business need and the intended audience with the request.
6 Request rules in the SOP mapSpeaker
Check the contract, the topic training, and the honorarium cap when the speaker is chosen. Flag a speaker already booked that day. Public payment data gives market context; it does not set fair market value.
7 Speaker rules in the SOP map
Over the cap? Can't be added.
Audience
Match each registration to one HCP record, from the client's CRM, its target list, or the NPI registry, and have a person confirm the match. Check each HCP's attendance limit when they are added or register, including on their own phone.
5 Audience rules in the SOP mapVenue & meals
Check the venue when it is chosen, and meal cost per attendee at reconciliation. Virtual programs carry no meal costs.
4 Venue & meals rules in the SOP mapProgram night
Each HCP signs in personally, and a walk-in signs in on the spot. A walk-in added after the program needs a reason.
4 Program night rules in the SOP mapClose-out & reporting
A program closes only when every attendee is matched to one HCP record or marked as not an HCP, its records and actual spend are in, and each HCP's share of the spend is allocated. Spend per HCP exports for Open Payments and state reports, and attendance goes back to the client's CRM.
10 Close-out & reporting rules in the SOP mapThe full list of common rules, with the moment to check each, is in the SOP checklist.
Same rules for virtual and hybrid
Virtual and hybrid programs add invitation, identity, access, attendance, and reconciliation paths. Apply the client’s rules, and the same named review, to every format. Online attendance comes from the meeting itself, and virtual programs carry no meal costs.
Ten questions
- Can the team produce the complete record of a program that closed 18 months ago?
- Does the attendance rule apply on every path an HCP can come in by?
- Can the team identify who confirmed the last attendance reconciliation?
- Is every attendee matched to one HCP record before close, and does the export read that record?
- Can every honorarium be traced to its contract, cap, context, and approval?
- Can meal spend be connected to actual attendees before close-out?
- Do voids and corrections remain visible?
- Is Open Payments preparation a controlled export or a quarter-end reconstruction?
- When a rule flags or blocks an action, is the resolution recorded?
- Can the platform show each answer on one of your own programs?
The public enforcement actions referenced in this article are cited for context; the companies involved are not Pharmagin customers. Pharmagin is software, not legal counsel. Nothing in this guide is legal advice.
Common questions
What does OIG look for in a speaker program?
Its 2020 Special Fraud Alert lists suspect characteristics such as little substantive content, meals beyond modest value or alcohol, venues not suited to education, repeat attendance, attendees without a reason to be there, speakers chosen for sales reasons, and pay above fair market value.
Does OIG set a limit on how often an HCP can attend?
The 2020 alert lists HCPs attending programs on the same or substantially the same topic more than once as a suspect characteristic. It lists characteristics, not a fixed limit, so each pharma company sets its own limit in its SOP, for example one program per topic in any 12 months. The limit should be checked whenever an HCP is added or registers.
When is Open Payments data due?
Companies submit between February 1 and March 31. HCPs review and dispute it from April 1 to May 15, and CMS publishes it by June 30.