Section 6002 of the Patient Protection and Affordable Care Act (PPACA), pursuant to a provision referred to as the “Sunshine Law”, requires certain manufacturers (“applicable manufacturers”) of drugs, devices, biologicals, or medical devices covered under Medicare, Medicaid or the Children’s Health Insurance Program (“CHIP”) to report annually certain payments or other transfers of value to physicians and teaching hospitals (referred to in the statute as “covered recipients”) during the course of the preceding calendar year. Applicable manufacturers must report the required payment and other transfer of value information to the Center for Medicare and Medicaid Services (CMS) to an electronic format by March 31, 2013, and on the 90th day of each calendar year thereafter. Applicable Manufacturers are subject to civil monetary penalties for failing to comply with the reporting requirements. CMS is required by the statute to publish the reported data on a public website. The data must be downloadable, searchable and easily aggregated. In addition, CMS must submit annual reports to Congress and each State summarizing the data reported.
The statute requires the following information to be reported with respect to the preceding calendar year:
(I) cash or cash equivalent;
(II) in-kind items or services;
(III) stock, a stock option, or any other ownership interest, dividend, profit, or other return on investment; or
(IV) any other form of payment or other transfer of value (as defined by the Secretary). Other transfer of value, such as –
(1) consulting fees;
(2) compensation for services other than consulting;
(7) travel (including the specified destinations);
(10) charitable contribution;
(11) royalty or license;
(12) current or prospective ownership interest;
(13) direct compensation for serving as faculty or as a speaker for a medical education program;
(14) grant; or
(15) any other nature of the payment or other transfer of value (as defined by the Secretary).
If the payment or other transfer of value is related to marketing, education, or research specific to a covered drug, device, biological or medical supply, the applicable manufacturer must identify the name of the covered drug, device, biological or medical device.
The Sunshine Act provides some exceptions to the reporting requirement:
- (i) A transfer of anything of value which is less than $10.00, unless the aggregate amount transferred during the calendar year exceeds $100.00.
- (ii) Product samples that are not intended to be sold and are intended for patient use;
- (iii) Educational materials that directly benefit patients or are intended for patient use.
- (iv) The loan of a covered device for a short-term trial period, not to exceed 90 days, to permit evaluation of the covered device by the covered recipient.
- (v) Items or services provided under a contractual warranty, including the replacement of