Complete guide for Sunshine Act compliance and transfer of value documentation.
What is the Sunshine Act?
The Physician Payments Sunshine Act is a federal transparency law requiring pharmaceutical and medical device manufacturers to report payments and transfers of value to healthcare providers.
Why It Matters:Manufacturers must submit Open Payments data annually to CMS. Failure to report or inaccurate reporting can result in fines up to $1.15 million per year.
Types of Transfers of Value
The Sunshine Act requires reporting of various value transfers:
Consulting Fees
Payments for advisory board participation, consulting services, strategic advice
Speaker Honoraria
Compensation for speaking at conferences, grand rounds, CME events
Food & Beverage
Meals provided at events, even modest value (coffee/bagels require reporting)
Travel & Lodging
Airfare, hotel, ground transportation, parking for attendees
Gifts & Entertainment
Items of value provided to HCPs (many companies have policies prohibiting this)
Education (non-CME)
Company-sponsored training not qualifying as accredited CME
Reporting Thresholds
Federal (Sunshine Act)
Individual payments $10 or more: Must be reported if annual aggregate to one HCP exceeds $100
Payments under $10: Not reported unless aggregate exceeds $100
No minimum for ownership/investment interests: All must be reported
State-Specific Requirements
Some states have additional or different thresholds:
Vermont
Annual reporting required for all payments (no minimum threshold)
Includes prescription device marketing
Massachusetts
$50+ per item or $1,000+ annual aggregate to one HCP
Stricter than federal
Minnesota
$50+ per item or $100+ annual aggregate
State AG reporting
California
Voluntary compliance (no state law currently)
Follow federal rules
Configuring TOV Tracking in MyEventsAI
1
Enable TOV Tracking
In HCP event wizard, toggle "Track Transfer of Value" in Compliance tab
2
Specify Value Types
Select all applicable: meals, honoraria, travel, consulting, etc.