In a pair of proposed rules released by the Department of Health and Human Services (DHHS), Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS), the DHHS is looking to increase the utilization of value-based arrangements to drive health outcomes and ease the regulatory burdens associated with patient care coordination. The proposed rules seek to change or add certain safe harbors or exceptions to the Anti-Kickback Statute (AKS), Physician Self-Referral prohibition (Stark Law), and the Civil Monetary Penalties (CMP) laws.
This Advisory Opinion demonstrates OIG’s willingness to remove barriers to adoption of healthcare technologies - such as lack of access to a smartphone - that may improve patient outcomes and reduce overall costs of care.
On September 27, 2018, the Department of Justice (“DOJ”) for the first time announced its own “road map” guiding voluntary self-disclosures and cooperation with government investigations of fraud and abuse in the healthcare industry. By encouraging self-disclosure, the government is incentivizing healthcare entities to come forward early with reports of violations in the hope of negotiating reasonable settlements, avoiding exclusion from Federal healthcare programs, and reducing the severe civil and criminal penalties that would otherwise be imposed for such violations.
Five new safe harbors have been added to the Anti-Kickback Statute (AKS) in the final rule, issued on December 17, 2016 by the Health and Human Services Office of the Inspector General (OIG). In addition, existing safe harbors have been revised to grant further protections to providers from criminal prosecution and civil damages. What these changes mean for providers: The trend in healthcare is to move from volume-based care to value-based care.