In October 2019, as part of HHS’ Regulatory Sprint to Coordinated Care, long-awaited rules were proposed by HHS and CMS regarding changes to the Stark Law and Anti-Kickback Statute (AKS). These rules were the byproduct of many years of effort by both the federal government and the health care industry to streamline the fraud and abuse statutes in a manner that would promote value-based payment arrangements and the overall industry push to coordinated care.
Obviously much has changed since last October, and currently the proposed rules are still under consideration by the White House Office of Management and Budget in conjunction with the Trump administration’s request to make implementation of the new rule changes conditional on the inclusion of additional price transparency requirements that would require providers to give patients information about their out-of-pocket costs for referred items and services. As noted in a recent Modern Healthcare article, many key industry providers are actively lobbying the White House to approve the proposed changes without these price transparency conditions and therefore implement the more streamlined regulatory landscape that they have actively worked to develop.
It remains to be seen whether these lobbying efforts will be successful as the current health care regulatory environment has been complicated significantly by the ongoing COVID-19 crisis and the political debate surrounding the health care response to the crisis. We will continue to monitor and keep you apprised of the latest developments because these changes, if implemented, will have a significant impact on the reach of both Stark and the AKS with respect to the ongoing efforts to move toward a more coordinated, value-based care environment.