Federal lawmakers are debating legislation to address surprise medical bills that, if passed in its current form, would significantly impact how hospitals, physicians and insurers negotiate payment for the provision of certain out-of-network services. A bipartisan coalition led by Senator Lamar Alexander (R-Tennessee), Chairman of the Senate Health, Education, Labor and Pension Committee, and Senator

On July 8, 2019, Anthony Camillo, owner of Allegiance Medical Laboratory and AMS Medical Laboratory, was sentenced to 30 months in prison by a federal judge in the Eastern District of Missouri. He was ordered to pay $3.4 million in restitution for violations of the anti-kickback statute, associated conspiracy charges, and illegal kickbacks related to

On May 7, 2019, the Department of Justice (“DOJ”) released new guidance for trial attorneys in the DOJ’s civil division regarding how entities under False Claims Act investigation can receive credit for cooperation.  The release of this new guidance follows public comments delivered in March by Michael Granston, director of DOJ’s civil fraud section, noting

On Friday April 26, 2019, the US Department of Health and Human Services (“HHS”) issued a notification regarding HHS’ use of Civil Monetary Penalties (“CMP”) under the Health Insurance Portability and Accountability Act (“HIPAA”) as amended by the Health Information Technology for Economic and Clinical Health (“HITECH”) Act.  https://www.federalregister.gov/documents/2019/04/30/2019-08530/enforcement-discretion-regarding-hipaa-civil-money-penalties.  The notice provides: “As a

The Centers for Medicare & Medicaid Services (“CMS”) has published a final rule that will expand access to telehealth services for Medicare Advantage (“MA”) plan enrollees.[1] CMS Administrator Seema Verma characterized the agency’s latest policymaking efforts as “a historic step in bringing innovative technology to Medicare beneficiaries” and a way for the agency to

On April 2, 2019, FDA issued a press release featuring a statement from FDA Commissioner Scott Gottlieb announcing the Agency’s latest enforcement actions taken against companies engaging in unlawful marketing of cannabidiol (CBD) products.  Coming just days before Gottlieb’s anticipated departure from the Agency, this news otherwise is unsurprising given recent events on the federal

Despite recent welcome news to the home health agency (“HHA”) industry in Florida, Illinois, Michigan, and Texas following an end to Centers for Medicare & Medicaid Services’ (“CMS’s”) long-standing HHA provider enrollment moratoria, CMS subsequently announced that it would place some newly enrolled HHAs in a provisional period of enhanced oversight. The purpose

On March 15, 2019, the Centers for Medicare & Medicaid Services (CMS) released proposed changes to its methodology for calculating Civil Money Penalties (CMPs) for Medicare Advantage (MA) and Part D Prescription Drug Plan (MA and Part D) sponsors.  The proposed changes would impact both the calculation methodology for 2019 as well as the CMP

Consumer privacy protection continues to be top of mind for regulators given a climate where technology companies face scrutiny for lax data governance and poor data stewardship.  Less than a year ago, California passed the California Consumer Privacy Act (CCPA) of 2018, to strengthen its privacy laws.  In many regards, the CCPA served as