The Physician Payment Sunshine Act (PPSA), also known as the Sunshine Act, requires applicable pharmaceutical and medical device manufacturers to track and report all expenses, payments or transfers valued at more than $10 provided to any physician or teaching hospital. These “payments” include travel expenses, samples, meals, speaking fees, or research payments.
The tracking of the payment data must be done at the individual Health Care Professional (HCP) level, once compiled the data must then be submitted to the CMS.gov OpenPayment portal in a specific format. Once validated by the individual HCP the data will be compiled by the government and made available for public scrutiny.
Non-compliance will have severe financial consequences for each violation—that data will also be published publicly.
All applicable companies must be compliant as of August 1, 2013; the data collected from August through December 31, 2013 must be submitted to the CMS.gov Open Payment portal by March 31, 2014. After validating the payment data with the each HCP, the CMS will publicly publish the details by September 30, 2014.
More importantly will the Sunshine Act affect your company, and how?
If you are a pharmaceutical or medical device manufacturer, or Group Purchasing Organization (GPO) that has HCP payments that are reimbursed in the United States, regardless the region of the world your company is physically located, then you are subject to these compliance regulations!
If your organization is like most you have multiple AP, ERP and NPI systems that house all of the pertinent data that will need to be collected. You will have to take on the additional overhead to manually identify each HCP and then track back every payment that has been submitted—which will quickly become a nightmare if your employees have not properly documented each transaction. After collecting the data you then have to validate that you have all of the required CMS.gov Open Payment data (HCP Degree Information, Ownership/Investment Interests, “Agreement to Disclosure” documentation, etc.) and subsequently consolidate all of that data and submit it on time.
If you are not fully automated this process will impact your bottom-line and negatively affect your company’s public image!