Yesterday during the Federal Bar Association’s 2021 Qui Tam Conference, Charlene Keller Fullmer, the Civil Assistant Chief for the Eastern District of Pennsylvania, discussed how enforcement actions involving violations of the Sunshine Act are poised to increase, aided by data analytics.
This past October, for the first time, DOJ announced a global settlement resolving allegations that a manufacturer paid kickbacks to a physician and that the defendant failed to report these payments under the Open Payments Program. This program, operated by the Centers for Medicare & Medicaid Services (“CMS”), implements a requirement in the Sunshine Act that requires applicable manufacturers and group purchasing organizations to report a variety of transfers of value to certain health care providers. Effective this year, CMS expanded the reporting obligations to include additional provider types such as physician assistants and nurse practitioners. Although reporting began in 2014, CMS has announced very little enforcement scrutiny or auditing to date, and the October DOJ announcement marked the first major enforcement action in this space.
Fullmer, whose office has been on the leading edge of enforcement in the industry, noted that the government will be assessing a defendant’s course of conduct as a whole to determine whether it is appropriate to incorporate Open Payments Program violations into a global settlement resolving Anti-Kickback Statute violations. Fullmer also explained that while DOJ so far has used Open Payments data “to support and bolster cases that have already been filed,” DOJ may make more proactive use of the Open Payments data to identify conduct for potential enforcement. These remarks are consistent with earlier comments—made at the same conference by acting head of the DOJ Civil Division Brian Boynton (discussed here)—regarding the growing importance of data analytics for DOJ, both in assessing whistleblower allegations and identifying new targets for enforcement.