Guest Post from Maya A. Babu, MD
Neurosurgical Resident, Mayo Clinic
Rochester, MN
Representing the American Medical Association (and neurosurgery) I participated in an important panel session on the Sunshine Act (specifically on the Open Payments Database) during the 15th Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum sponsored by the Pharmaceutical Compliance Forum in Washington, DC. The target audience was those who worked in pharmaceutical compliance. Crucial concepts discussed included:
- The current state of the data
- The challenges faced in corporate compliance with the regulations
- The problems with the reporting system as presently configured
- The potential impact on organizations within medicine
Doug Brown, Director of the Data Sharing and Partnership Group of the Centers for Medicare & Medicaid Services (CMS), spoke about the published and missing data. Key information given included:
- 2.7 million identified records published along with 1.7 million de-identified records
- 199,000 remain unpublished
- $3.5 billion in value published
- $1.1 billion remains unpublished (NB: Just 199,000 records involve $1.1 billion in value A rather disturbing figure)
- 9000 records are in dispute
- 190,000 have been marked for delayed publishing, due to granting requirements, patent applications, or other restrictions.
He also spoke of the “context” feature on the website which he feels has not been appropriately utilized. This portion of the website provides scant explanation for what the transfers of values included, such as research versus education versus meals.
Other panelists were Charles Ornstein, a reporter with ProPublica, John Murphy of PhRMA, Maggie Feltz of Purdue Pharmaceuticals, and Cindy Bongiovanni of Bristol Meyers Squibb. These panelists noted critical information deficiencies including the inaccuracy of the attributions in the database. For instance, pharmaceutical payments listed as device payments, and vice versa. The pharmaceutical compliance officers decried the challenges of accurate reporting in terms of recording transfers of value and transmitting this information to CMS. The industry voiced additional concerns about how tedious it was to track transfers of value for “nominal” amounts (the standard for reporting is any item greater than $10) and the amount of manpower, time, and record-keeping required to accurately track the volume of this information.
Neurosurgery supports and welcomes transparent physician-industry interactions to foster healthy relations and spur innovative device development to benefit patients. Within the relatively small specialty of neurosurgery, there are numerous examples of just such benefit such as the growth of effective Deep Brain Stimulation, and the resulting benefits this technology has provided countless patients.
However, neurosurgery has serious ongoing concerns about the Open Payments Database, including:
- Accuracy of the attributions for transfer of value (whether it was for meals, or education, or research) as well as the amount of the value transfer cited
- Transparency in terms of the stated context for the transfer of value (i.e. research grants are appropriately explained and not confused with “salary”).
- The chilling effect on education with medical textbooks and journal reprints included for reporting under the Sunshine Act. This particularly impacts neurosurgeons in underserved or rural communities without a close affiliation to an academic center.
Finally, for all of organized medicine, there is a new dilemma posed by transparency websites including Open Payments. What will be the impact of failure to disclose this data in other components of our professional activities and how can or should this be monitored? While questions such as these may seem outlandish, as more information is publicly released by the administration, and more news outlets delve into the numbers, it is important for all to consider all the implications of disclosure, transparency, and context.
