The Stark Law regulations are not without controversy, as an unsuccessful appeal by a group of urologists brought against the Centers for Medicare & Medicaid Services illustrates.

Considering the first attempt at such legislation was a mere two years ago, one has to wonder: will things be different this time around?

When the Centers for Medicare & Medicaid Services published the final rule implementing the Physician Payments Sunshine Act last month, it ushered in a new regulatory landscape.

On November 18, 2022, the U.S. Department of Justice (DOJ) announced charges against 10 defendants in its first coordinated action against individuals using business email compromise (BEC),...

On an episode of Connected Nation, Lara Compton and Jean Krebs examined a report from the White House Office of National Drug Control Policy...

Our colleagues at ML Strategies have provided their Fall Health Care Preview for Fall 2017. This preview focuses on what to expect for the rest of 2017 by examining the following questions:

Joanne Hawana discusses recent actions taken by FDA with regard to regenerative medicine including clarifying what technologies fit within the rubric, the announcement of a wholesale review of polices...

As an update to my post on Friday, April 22, FDA has extended the deadline for comments on third-party servicing of medical devices.

Joanne Hawana explains how FDA regulatory due diligence fits into the broader diligence that is done when a transaction involves an FDA-regulated entity...

On Mintz Levin's Health Law and Policy Matters blog, our colleague Joanne Hawana discussed the August 7 Warning Letter sent by FDA to the drug company Duchesnay, Inc...

Late Monday night (February 5, 2018), the House of Representatives released a continuing resolution to keep the government funded and running until March 23, 2018.

The health care industry is familiar with the FTC’s enforcement presence for anticompetitive business practices in health care markets.

The Federal Trade Commission issued a policy paper in an effort to urge state legislators to open health care markets to a broader range of providers.

Earlier this week my colleagues, Bruce Sokler and Farrah Short published an alert detailing the FTC‘s creative solution to permit a presumptively anticompetitive merger for a financially failing medical practice.

The 21st Century Cures Act includes substantial changes to the FDA's regulation of medical devices.

On July 1, 2016, Vermont's Act 120 will require food manufacturers to indicate in the labeling of all products regulated by FDA when the food has been produced with the use of genetic engineering (GE).

Bruce Sokler discusses the Supreme Court’s first ever health care antitrust merger decision and its implications for the future.

Our Health Care Enforcement Defense Practice has published its most recent Qui Tam Update analyzing 68 recently unsealed health care related whistleblower cases.

Brian Platton provides an overview of enforcement trends that private equity investors should be aware of before entering into the health care space.

Our colleagues at ML Strategies have provided a Health Care Weekly Preview. This week?s preview describes the ongoing wrangling in the Senate over health care reform...