The Sunshine Act requires manufacturers to disclosure payments, transfers of value and ownership/investment interests.
Direct and indirect payments and transfers of value must be reported when:
- An item is worth $10 or more; or
- The sum of all annual gifts to a particular recipient exceeds $100 (for items worth less than $10 each).
Manufacturers are also required to report payments and transfers of value made to a third party at the request of or on behalf of a physician.
Note: Speaking or consulting fees that physicians ask be donated to a charitable organization will be reported as directed to the physician.
Ownership and investment interests
Group purchasing organizations and manufacturers must report any and all such interests held by physicians or their immediate family members.
Payments related to research must be reported separately and submitted the year the payment occurs, stating the institution name and principal investigators. Some details may qualify for delayed publication to the public CMS website.
Manufacturers will be subject to penalties for non-compliance with the law or false reporting.
All reports must include:
- Manufacturer or group purchasing organization name
- Physician’s name and business address
- Physician’s specialty, NPI and state professional license number
- Dollar value and date of the payment/transfer of value
- Form of payment/transfer of value (e.g., cash/cash equivalent)
- In-kind items/services; stock, stock option or any other ownership interest; and dividend, profit or other return on investment
- Nature of payment/transfer of value, using one of the following pre-defined categories (NOTE: Some exclusions apply to CME):
- Consulting fee
- Compensation for serving as faculty or as a speaker for an accredited or certified CME program
- Compensation for serving as faculty or as a speaker for an unaccredited and non-certified CME program
- Compensation for services other than consulting, including serving as faculty at an event other than a CME program
- Food and beverage
- Travel and lodging (including specifying the destination)
- Charitable contribution
- Royalty or license
- Ownership or investment
- Interest (current/prospective)
- Space rental or facility fees (teaching hospital only)
- Device product name, therapeutic area or product category related to the payment/transfer of value
- Optional context – i.e., brief description of the context of the payment/transfer of value
- Name of entity that received the payment/transfer of value, if not provided to the physician directly (e.g., charity)
- Whether the payment/transfer of value was provided to a physician holding ownership/investment interests in the manufacturer and if so, who holds the ownership/investment interest
For investment/ownership interests, reports must also include:
- Dollar amount invested;
- Value and terms of the ownership or investment interest (excluding interests in publicly traded securities or mutual funds); and
- Any payments/transfers of value provided to the physician owner or investor.