Benjamin Wallfisch (US)

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FDA announces plans to create a centralized digital health unit

The U.S. Food and Drug Administration (“FDA”) has announced plans to create a centralized digital health unit within the Center for Devices and Radiological Health (“CDRH”), further supporting CDRH’s 2016-2017 vision to establish a more robust national evaluation system for medical devices.  FDA will form the new digital health unit within CDRH’s Office of the … Continue reading

CMS releases Open Payments data refresh

This week, the Centers for Medicare and Medicaid Services (CMS) published a refresh of its Open Payments dataset, which includes new data to account for the result of disputes and other data corrections since the last refresh in June 2016. Note that this release does not yet include 2016 data, which should be published in … Continue reading

2015 CMS “Open Payments” data released

Last week, CMS posted the 2015 Open Payments data to its website, as well as updated payment records for 2013 and 2014.  Overall, manufacturers reported $7.52 billion in payments and ownership interests to 618,931 physicians and 1,116 teaching hospitals in 2015.  Nearly 1,500 companies reported making payments in 2015, comprising a total 11.9 million records.  … Continue reading

Ninth Circuit approves enhanced sentences for “abuse of trust” in health care fraud case

In a decision that could have wider ramifications for sentencing in health care fraud cases, a Ninth Circuit panel last week affirmed a lower court’s sentencing enhancement, applied because the defendants were found to have abused a “position of trust” by submitting false information in Medicare claims. The case involves owners of a California-based DME … Continue reading

Two new OIG reports signal intensified scrutiny on Medicare Part D fraud

On the heels of the largest nationwide health care fraud takedown in history announced last week, the federal government on Tuesday issued two new reports detailing what it believes to be extensive evidence of suspicious billing under Medicare Part D. The move signals that the prescription drug benefit program can expect significant enforcement actions in … Continue reading

Feds unveil sweeping Medicare fraud “takedown”

On June 18, Federal officials announced criminal enforcement actions against 243 individuals across the country. The nationwide arrests mark the largest criminal health care fraud takedown in history and came as a result of Medicare Fraud Strike Force investigations. The Attorney General, HHS Secretary, and FBI Director announced the charges, which allege various health care … Continue reading

DOJ recovered US$2.3Bn from healthcare FCA cases in FY 2014

In FY 2014, for the fifth consecutive year, the Department of Justice (“DOJ”) recovered more than US$2 billion from healthcare entities in False Claims Act (“FCA”) cases. The federal government collected a total of US$5.69 billion overall in FCA actions in FY 2014, and US$2.3 billion of that amount was from healthcare-related FCA actions, according … Continue reading