As this year’s Sunshine Act filing deadline rapidly approaches, companies are busy preparing and validating aggregate spend data.
With data so readily available, CMS has also taken a more compliance-driven focus to their role in transparency reporting. As discussed in an open Q&A session with CMS this Wednesday, March 8th, CMS started issuing letters of education to companies who attested late in 2014 and 2015. Although the issuance of these notices is in their infancy, CMS addressed questions they have been receiving from applicable manufacturers who have received such communications.
CMS described the intent of the letter as educational – to notify manufacturers of late attestations during previous reporting years. Instances that would initiate the notification were outlined during the live session. Examples include:
- Companies that discovered and reported transactions for a previous reporting period after the filing period had concluded (although this is a required practice as mandated by the Final Rule) may be subject to this communication.
- Transactions updated as part of the dispute resolution process may warrant the notification. CMS concluded that while the education letters do not require applicable manufacturers to take compliance action, individual scenarios that may warrant late attestations should be outlined in the company’s assumptions letter.
CMS concluded that while the education letters do not require applicable manufacturers to take compliance action, individual scenarios that may warrant late attestations should be outlined in the company’s assumptions letter.
CMS’ new compliance initiative is the latest in the industry’s overall trend towards a heightened compliance focus. With enforcement actions continuing to increase (for both large and small companies), the OIG has acknowledged a focus on kick-back issues in 2017. With a heavier degree of scrutiny around the educational effectiveness and validity of Speaker Programs and compliant management of third party vendors (to name a few), companies are taking a more introspective look at policies, processes, and data management to ensure regulatory compliance. This proactive, rather than reactive focus has created a noticeable trend in developing robust sub-certification and monitoring processes, and less focus on downstream auditing.
As these trends continues to evolve, the role of technology and automation can minimize the risk of manual and process driven solutions. When knowledge (and data) is power, scaling and implementing automation into business processes allows for cross-functional visibility into the effectiveness of engagements and activities.