Speaker Bureau & Educational Programs Flashcards

What is the primary purpose of a healthcare industry speaker bureau?

Answer: To manage a roster of qualified healthcare professionals who educate peers about disease states and treatments

Speaker bureaus manage qualified healthcare professionals who deliver company-sponsored educational programs to their peers on relevant disease states and therapies.

Under PhRMA guidelines, which criterion is MOST important when selecting healthcare professionals to participate in a speaker bureau?

Answer: The speaker's demonstrated clinical expertise and professional qualifications relevant to the topic

PhRMA guidelines require that speakers be selected based on their genuine clinical expertise and qualifications relevant to the educational topic, not prescribing patterns or personal relationships.

Which federal law requires pharmaceutical manufacturers to report payments made to physicians for participation in speaker programs?

Answer: Physician Payments Sunshine Act (Open Payments)

The Physician Payments Sunshine Act, implemented as the Open Payments program under the ACA, mandates that manufacturers report all payments to covered recipients, including speaker fees.

According to PhRMA guidelines, speaker programs must be held in settings that are:

Answer: Conducive to the transmission of medical information and appropriate for an educational program

PhRMA guidelines specify that venue selection must support the educational purpose; lavish or resort settings that suggest entertainment over education are prohibited.

What is 'fair market value' (FMV) as applied to speaker compensation in healthcare compliance?

Answer: The amount a willing buyer would pay and a willing seller would accept for a service in an arm's-length transaction

FMV is an arm's-length transaction standard used to ensure speaker fees reflect the genuine value of the service and are not disguised remuneration that could implicate the Anti-Kickback Statute.

Which of the following is expressly prohibited under PhRMA guidelines for company-sponsored speaker programs?

Answer: Using the same speaker repeatedly in a market without a legitimate educational need

Repeated speaker programs in the same geographic area without demonstrated educational need raise compliance concerns and are flagged as potentially serving a promotional rather than educational purpose.

What documentation must a company maintain for each healthcare professional speaker program to demonstrate compliance?

Answer: Attendee sign-in sheets, speaker contracts, topic materials, venue invoices, and meal receipts

Comprehensive documentation—including attendee records, contracts, educational content, venue costs, and meal receipts—is required to demonstrate that programs met compliance standards and to support Open Payments reporting.