What is the legislation?
The Physician Payments Sunshine Act, or "Sunshine Act" passed as part of the Patient Protection and Affordable Care Act in the U.S. (health care reform) in 2010. It’s designed to bring transparency to financial relationships between physicians, teaching hospitals, and the pharmaceutical and medical device industry. Effective August 1, 2013, the Sunshine Act requires manufacturers of pharmaceutical drugs and devices, as well as group purchasing organizations (GPOs), to report payments or transfers of value (e.g., gifts, honoraria, or travel reimbursement) made to U.S. physicians and teaching hospitals. Reports are made annually to the Centers for Medicare and Medicaid Services (CMS), and will be posted on a public website.
Data collection for reporting began on August 1, 2013. Physicians have the ability to review their reports and to challenge reports that are false, inaccurate, or misleading by registering at the CMS website.
What needs to be reported?
Whether made directly to a physician or teaching hospital or indirectly through a third party, manufacturers must report all payments or transfers of value—including payments for
- speaking fees
- educational items like textbooks and journal reprints
At this time, medical students, residents, support and office staff, nurses, advance practice nurses, physician assistants, and other non-physicians are excluded from reports.
What must be reported?
Manufacturers are required to report identifying information about the physician to whom the payment was made, including their name, business address, specialty, NPI and license number, the nature and amount of the payment or transfer, and any explanatory details. Where applicable, the name of the manufacturer’s product(s) related to the payment or transfer must also be reported.
Physicians will not be responsible for reporting any information to CMS, but may be asked to provide the information to a manufacturer or a third party so that it can be included in a report.
What's the impact for publishers?
Publishers that provide educational materials, references, article reprints, or any published print or digital product to pharmaceutical companies or hospital teaching institutions are impacted by this legislation. Annual reporting must be delivered to the CMS following the submission file specifications (formerly known as data collection templates). The submission file specifications provide a list of the data elements that must be collected and reported.
What's a publisher to do?
Automating the collection and reporting of Sunshine Act disclosure information with secure and reliable data is critical for publishers who deliver content to physicians and teaching hospitals. Cenveo Publisher Services has a long history of developing technologies that support the STM market.
Cenveo Mobile dPub is an online platform that easily transforms content into a digital publication that can be read
- on any mobile device as a native application
- via a web browser on any device connected online
- inside Apple Newstand and available for download
Standard and custom data capture from users accessing the content is built into the system. This means article reprints delivered as digital downloads or PDFs require a login that includes a National Provider Identifier (NPI), state license number, as well as any additional information publishers deem necessary.
The collected data is easily exported based on the publishers reporting deadlines and delivered in the required format. The system is set up to configure automated data export and file validation.
As the age of big data continues to surge around the distribution and collection of content, we provide solutions to navigate and thrive in this brave new world.