As another part of the Regulatory Sprint to Coordinated Care, OIG proposed revisions to the existing EHR Anti-Kickback Safe Harbor and added a cybersecurity component. The initial EHR Safe Harbor was developed in response to President George W. Bush’s 2004 initiative to extend EHR nationwide within 10 years, i.e. 2014.  The proponents of those EHR regulations presumably thought the task would be completed within that time frame, because the initial proposal had a 10 year…

On November 7, 2019, the U.S. Department of Health and Human Services, Office for Civil Rights (“HHS”) announced a $1,600,000 civil money penalty for violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security and Breach Notification Rules. According to HHS, the Texas Health and Human Services Commission (TX HHSC) “operates state supported living centers; provides mental health and substance use services; regulates child care and nursing facilities; and administers hundreds of…

On October 22, 2019, CMS and OIG (Office of Inspector General) released new proposed rules regarding Stark Law Exceptions and Anti-Kickback Safe Harbors in response to what has universally been christened as the “Regulatory Sprint to Coordinated Care”, first announced by HHS in June of 2018. As background, please remember that, although the Anti-Kickback Safe Harbors and the Stark Law Exceptions are confusingly similar with respect to their intended purpose, they serve the following different…

The federal government/Trump administration announced today a delay regarding a proposed rule requiring hospitals to disclose actual negotiated price rates.  See WSJ News. In January, 2019, as reported in the MedLaw Blog on January 10, 2019, CMS added a rule requiring hospitals to publish their standard charges beginning January 2019. As noted in that blog post, requiring the “charge master disclosure” does not provide much in the way of transparency since so few…

On October 23, 2019, the U.S. Department of Health and Human Services, Office for Civil Rights (“HHS”) announced a $2,154,000 civil money penalty for numerous violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security and Breach Notification Rules between 2013 and 2016. According to HHS, Jackson Health System (“JHS”) is a medical system based in Florida and provides health care to 650,000 patients on average each year. According to the HHS…

HHS has long admitted that the Anti-Kickback Statute (AKS) and the Stark law have not evolved to keep pace with the transition to value based care.  In June of 2018, HHS issued an RFI seeking additional information and HHS also issued a release on December 12, 2018 seeking input on improving care coordination and reducing the regulatory burdens of the HIPAA rules. I would suggest that almost everybody else came to that conclusion much earlier…