Clinical Trials Reporting Under The Sunshine Act

The Sunshine Act was originally adopted as part of the Patient Protection and Affordable Care Act in March 2010 which requires pharmaceutical companies and medical device manufacturers to report annually to CMS about transfers of value they make to physicians and teaching hospitals. This information will be compiled by CMS and posted which can be accessed by public.

Physicians are not required to carry out any specific procedure under this act as they have been defined as “covered recipients” under the final rule but it is recommended for many physicians.

The information that physicians should expect applicable manufacturers to report are: the physician’s name, address, specialty, license information, NPI and details of payment made.

In the Sunshine Act there are some exclusions mentioned for educational materials that are for patient use or direct patient benefit, but all “educational materials” provided by a company will not be excluded. The reported items include: items provided for the education of physicians and marketing and promotional materials.

In order to adhere to this, companies should consider developing a method and process for assessing which items must be tracked and reported to satisfy state laws and the new Physicians Sunshine Act regulations and assigning a value to each of these items that is consistent across the company.

Some of the things to do to ensure a compliant practice are:

• Practices must take care to make sure that current organizational document, employment agreements, compliance policies, and conflict-of-interest disclosure procedures are updated.

• Under this act, physicians must request the ability to conduct a pre-submission review from the manufacturers and GPOs with which they have financial arrangements. If this is not available, physicians need to review and look-up for any loop-hole in the information.

• Physicians must make a note in their calendars to review the information reported to CMS. It is important to maintain accurate financial records to ensure that the information that has been submitted to CMS is accurate.

• If applicable manufacturers and GPOs fail to adhere to the Sunshine Act, they will face severe penalties, including a hefty fine of $1,000,000 for those that intentionally fail to report. This implies that the information provided will be published and it is necessary to steer-clear of scrutiny with regard to the information that they will provide.