Health Care

The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) recently announced the first ever settlement related to a Covered Entity’s untimely breach notification in violation of HIPAA.

ML Strategies has published its Washington Outlook for 2017, with a collection of materials covering what to expect from the 115th Congress, spanning multiple issues and industries.

The Massachusetts Department of Public Health (DPH) Determination of Need (DoN) Program has promulgated final DoN regulations.

As we enter a new era in which executive agencies are headed by President Trump, we are also faced with many other transformative changes that will affect FDA-regulated entities in a significant and lasting way. This post will outline some of our thoughts related to what could face FDA and its various stakeholders as we go forward into the great unknown.

Back in early October, we were all transfixed by the announced Mylan settlement with the U.S. Department of Justice (DOJ) over Mylan’s alleged underpayments of Medicaid Drug Rebates for the EpiPen.

On Monday, FDA issued a final rule to amend FDA’s established definitions of “intended use” for drugs and devices, the primary consideration in determining whether a product is regulated for a particular use and what regulations apply.

In this final installment of our Health Care Enforcement Review and 2017 Outlook series, we analyze health care enforcement trends gathered from 2016 civil settlements and criminal resolutions of health care fraud and abuse cases. Behind the headlines covering enormous recoveries in 2016, several themes are apparent.

While 2016 marked one of the least productive years in the history of Congress, the same cannot be said of health care enforcement and regulatory agencies. Perhaps motivated by the impending change in administration, these agencies promulgated a number of notable regulations in 2016.

Today, my colleagues Laurence Freedman, Samantha Kingsbury, and Karen Lovitch released the latest in our ongoing series reviewing health care enforcement activities in 2016 and their impacts looking forward to 2017.

Next Tuesday, January 12th, Mintz and ML Strategies will host the first installment of our three-part series focusing on the 21st Century Cures Act (“Cures Act”).  The Cures Act represents significant legislation that will have overarching implications on medical research, product development, and drug and biologic manufacturing.

Over the past year, clear trends have emerged in FDA’s enforcement activities. Enforcement arising from alleged violations of the Federal Food, Drug, and Cosmetic Act (FFDCA) can take many forms, including FDA advisory actions such as warning letters, adverse inspectional observations that can lead to specific administrative action.

Happy New Year! As we kick off 2017, our Health Care Enforcement Defense team brings you its annual review of key government policies, regulations, and enforcement actions in 2016, and the impact these trends are expected to have on enforcement in the year ahead.

On January 12th at 1:00pm EST, my colleague Susan Foster, PhD will present a webinar on Transferring Data from the EU.

Last week, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services released a report analyzing CMS' readiness to implement major parts of the Medicare Access and CHIP Reauthorization Act  of 2015 (MACRA).

Since congressional enactment and presidential signing of the Cures Act into law earlier this month, we have been blogging on discrete regulatory and clinical areas affected by its provisions.

As you have seen in our recent coverage, the 21st Century Cures Act is a major legislative undertaking, and it will have a great impact the medical device industry. Join my Mintz Levin and ML Strategies colleagues Tom Crane, Bethany Hills, and Rodney Whitlock on January 18th for a MassMEDIC webinar, “Impact of the Cures Act on the Medical Device Industry.”

As we noted in our December 9th post, the 21st Century Cures Act (the “Cures Act”) requires FDA to develop a framework and guidance for evaluating real world evidence (“RWE”) in the context of drug regulation to support approvals of new indications for previously approved drugs, and to support or fulfill post-approval study requirements.

The Centers for Medicare & Medicaid Services (CMS) has withdrawn its controversial rule implementing the Medicare Part B payment demonstration. The agency stated that after consideration of the comments, it will not move forward with the demo.

On Tuesday, President Obama signed the 21st Century Cures Act (the "Act”) into law. The Act is a massive piece of legislation that has implications for many different aspects of the interconnected medical research, product development, and health care delivery enterprises.

More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback Statute (AKS) regulatory safe harbors and adds protections for certain payment practices and business arrangements under the beneficiary inducement provisions of the Civil Monetary Penalty Law (CMP).