Initial Sunshine Act data released by CMS
On September 30, 2014, the Centers for Medicare and Medicaid Services (CMS) published the initial data detailing payments made by pharmaceutical manufacturers and medical device companies to physicians and teaching hospitals. The initial data in the so-called Open Payments database profiles payments made during the last five months of 2013 and includes information related to nearly 4.5 million payments representing roughly $3.5 billion made to approximately 550,000 doctors and 1,350 teaching hospitals.
Saul Ewing has previously written these articles about the enactment of the Sunshine Act as part of the 2010 Affordable Care Act and the subsequent implementation and delay in posting information in the Open Payments database:
- Sunshine Act Implementation Proceeds; CMS Re-opens the Open Payments System
- CMS Shuts Down Sunshine Act Online Verification Process
- CMS Proposes Elimination of CME Exception to Sunshine Act Reporting
- Enactment Of Sunshine Act Regulations Delayed; Will Require Manufacturers To Report Compensation Paid To Doctors
- Registration and Data Submission Begin Pursuant to the Sunshine Act
- Highlighting Transparency Through The Federal Sunshine Act Regulations
According to CMS, approximately 26,000 physicians and 400 teaching hospitals registered prior to the launch of the Open Payments database to review payments attributed to them. Physicians and teaching hospitals can go to http://tinyurl.com/cms-Registration-for-Physician to register to access the Open Payments system.
The Open Payments database records are divided into three categories: general payments, research-related payments, and physician ownership information.
“General Payments” includes payments or other transfers of value not made in connection with a research agreement or research protocol.
“Research Payments,” as its name suggests, includes payments or other transfers of value made in connection with a research agreement or research protocol.
“Physician Ownership Information” includes payments to physicians with an ownership interest in a manufacturer or so-called group purchasing organization (GPO) that buys a manufacturer’s products.
CMS has created a web link detailing the Open Payments initiative: http://tinyurl.com/cms-openpay. CMS has also created an FAQ section: http://tinyurl.com/cms-faqpage.
From CMS’ perspective, the Open Payments database provides the general public with information detailing financial relationships between physicians and teaching hospitals and applicable manufacturers and GPOs. CMS notes on its website – http://tinyurl.com/cms-openpaydata – the following four benefits of publishing this data:
- Encourages transparency about these financial ties;
- Provides information on the nature and extent of the relationships;
- Helps to identify relationships that can both lead to the development of beneficial new technologies and wasteful healthcare spending; and
- Helps to prevent inappropriate influence on research, education and clinical decision making.
CMS adds on the same website that, “Sharing information about financial relationships alone is not enough to decide whether they’re beneficial or improper. Just because there are financial ties doesn’t mean that anyone is doing anything wrong. Transparency will shed light on the nature and extent of these financial relationships and will hopefully discourage the development of inappropriate relationships.”
As noted in the Open Payments database fact sheet, http://tinyurl.com/cms-opendatapdf, the initial release of data by CMS was incomplete due to disputes about certain information submitted and potential inconsistencies in data. CMS anticipates addressing these issues internally, and with the assistance of manufacturers that may be asked to re-report data in 2015. Similarly, pharmaceutical manufacturers and medical device companies must continue to submit data to CMS related to payments to physicians and teaching hospitals for annual publication.
Physicians and teaching hospitals should review their posted information included in the Open Payments database and continue to review information reported by manufacturers in the future. Similarly, pharmaceutical manufacturers and medical device companies must continue to submit data to CMS related to payments to physicians and teaching hospitals for annual publication.
Transparency and data dissemination will continue to be a part of the public’s focus when reviewing issues within the health care delivery system. The Open Payments system will be an important part of that discussion.
Saul Ewing attorneys have experience with the Sunshine Act and health care compliance issues generally. For more information on these matters, please contact the authors or the attorney at the firm with whom you are regularly in contact.