In another sign that the Trump administration’s penchant for regulatory flexibility may apply to the federal fraud-and-abuse regulatory regimes, CMS administrator Seema Verma announced during an AHA Town Hall webcast on January 17 that CMS is convening an interagency group to examine possible ways to minimize the regulatory barriers of fraud-and-abuse laws, including the Stark Law. Interagency participants will include CMS, HHS’ Office of Inspector General, HHS’ General Counsel, and the Department of Justice.
During the town hall, Verma acknowledged the obstacles that fraud-and-abuse laws create for hospitals and other providers who want to explore CMS-created value-based payment opportunities. Verma stated that the Stark Law in particular “was developed a long time ago, and the payment systems and. . .how we are operating is different, and we need to. . .bring along some of those regulations and figure out what we can do.”
CMS relaxed its approach to the Stark Law through rulemaking in 2015, as covered here, which afforded significant new flexibility to providers. Although some discussion in this rulemaking began to lay the conceptual groundwork for even bolder Stark changes, tangible developments towards these changes were minimal until the task force announcement.
In a further sign of changes afoot, two recent DOJ memos signal shifts in how and when the DOJ will intervene in and seek to pursue False Claims Act allegations, including those grounded in agency guidance, rather than statutes and regulations. More about the implications of these memos can be found here.
We will closely monitor the progress of this task force, and include updates in our “New horizons in fraud & abuse” webinar slated for April 19. Register for the webinar now.