The United States recently passed the “Coronavirus Aid, Relief, and Economic Security Act” (CARES Act), sweeping legislation that could impact pharmaceutical and medical device companies with...
On October 13, 2019, California Governor Gavin Newsom signed into law Assembly Bill 744 (AB 744), marking the latest of many state legislative efforts to modernize health care by ensuring that te...
Last week marked the end of legislative activity in the state of California for 2019, and with the impending California Consumer Privacy Act (CCPA or the Act) going into effect on January 1, 2020...
The newly-enacted Bipartisan Budget Act of 2018 includes numerous Medicare, Medicaid, and other policy and payment provisions impacting health providers and manufacturers. Of particular note, the...
As covered in “Court Overturns $350 Million Judgment in FCA Case: Materiality, Scienter, and Causation Standards Preclude Liability by “’Zaps, Traps, and Zingers’”, Andy Bernasconi disc...
In France, transparency requirements are regulated by two main sets of laws: “The French Anti-Gift Law” regulates the provision of gifts, discounts and other incentives to health care provide...
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Cures Act). It is hoped that provisions in the new bill, and the $6.3 billion it provides for medical research ov...
The HHS Office of Civil Rights (“OCR”) published a final rule May 18, 2016, broadening the nondiscrimination requirements applicable to all health programs and activities receiving federal fi...
For some time, we have been reporting on issues involving federal government scrutiny of physician-owned distributors (“PODs”). From our blog post here on the Department of Health and Human S...
On February 9, 2016, the Obama Administration released its proposed fiscal year (FY) 2017 budget, which contains significant Medicare and Medicaid reimbursement and program integrity legislative ...