Medicaid, Food and Drug Administration (FDA), Department of Justice (DOJ)

Investigations Newsletter: Two Individuals Indicted for Operating $25 Million Crypto-Fraud

ArentFox Schiff on 12/18/2023

Two Individuals Indicted for Operating $25 Million Crypto-Fraud - On December 11, a federal court in California unsealed a superseding indictment, which charged two men with operating a $25 million cryptocurrency fraud...more

Investigations Newsletter: DOJ’s First Criminal Securities Fraud Prosecution Related to COVID-19 Results in Eight-Year Sentence

ArentFox Schiff on 10/23/2023

DOJ’s First Criminal Securities Fraud Prosecution Related to COVID-19 Results in Eight-Year Sentence - Mark Schena, the former president of Arrayit Corporation, a Silicon Valley-based medical technology company, was...more

Access to Care for Justice-Involved Pregnant People With a Substance Use Disorder

Manatt, Phelps & Phillips, LLP on 9/11/2023

There is a critical need to increase access to evidence-based care for justice-involved pregnant people with a substance use disorder (SUD)—and connect them to continued coverage and care upon release—according to national...more

Kitchen Sink MDRP Proposed Rule Radically Changes Best Price Determination Resulting in Financial and Operational Challenges for...

ArentFox Schiff on 6/9/2023

On May 26, 2023, the Centers for Medicare & Medicaid Services (CMS) released a Proposed Rule titled: “Medicaid Program: Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug...more

The State AG Report – Volume 7, Issue 34 | August 2021

Cozen O'Connor on 9/1/2021

Here are last week’s curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: Cannoli Factory Feels the Heat over Alleged Wage...more

Manufacturer of Defective Heart Devices Settles False Claims Act Case for $27 Million

Kohn, Kohn & Colapinto LLP on 7/16/2021

St. Jude Medical Inc. (“St. Jude”), which was acquired by Abbott Laboratories in 2017, entered into a settlement last week with the United States Department of Justice (“DOJ”) for $27 million to resolve allegations it had...more

FTC Under New Management | First Assertion Of The BOTS Act | Ash Cleanup Costs Redistributed

Cozen O'Connor on 1/29/2021

Breaking News- New Leadership at the FTC- •President Joseph R. Biden designated Federal Trade Commission (“FTC”) Commissioner Rebecca Kelly Slaughter as Acting Chair of the FTC . •As Commissioner, Chairwoman...more

Investigations Newsletter: DOJ’s 2020 False Claims Act Recoveries Lowest Since 2008

ArentFox Schiff on 1/25/2021

DOJ’s 2020 False Claims Act Recoveries Lowest Since 2008 - On January 14, 2021, the Department of Justice (DOJ) announced that it obtained more than $2.2 billion in settlements and judgments from civil cases involving...more

Washington Healthcare Update - October 2020 #1

McGuireWoods Consulting on 10/6/2020

This week in Washington: The Continuing Resolution (CR) to fund the government until Dec. 11 was signed by President Trump; House passes COVID-19 stimulus bill....more

Washington Healthcare Update - August 2020 #4

McGuireWoods Consulting on 9/1/2020

This week in Washington: Congress remains in a district work period, while COVID-19 legislative talks continue....more

Healthcare Fraud & Abuse Review 2017

Bass, Berry & Sims PLC on 3/13/2018

A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

As Congress Struggles With ACA Repeal, Trump Administration Moves Forward With Regulatory Reform

Skadden, Arps, Slate, Meagher & Flom LLP on 1/31/2018

The Trump administration and Republican-led Congress spent substantial time and political capital in 2017 on efforts to repeal and replace the Affordable Care Act (ACA) and enact sweeping Medicaid reform. By the end of the...more

Healthcare Law Update: June 2017

Holland & Knight LLP on 6/7/2017

Medicaid - Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law - By Eddie Williams - In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more

Washington Healthcare Update

McGuireWoods LLP on 10/11/2016

This Week: Congress remains in recess, but members write letters on Mylan’s EpiPen…CBO says repealing Part B Demo would cost $395 million…CMS releases data on hospice utilization and finds spending and utilization vary in...more

Health Update - July 2016

Manatt, Phelps & Phillips, LLP on 7/28/2016

The Vulnerability of Healthcare Information - According to a report the Brookings Institute issued in May 2016, 23% of all data breaches occur in the healthcare industry. Nearly 90% of healthcare organizations had some...more

A&B Healthcare Week in Review

Alston & Bird on 3/25/2016

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

Washington Healthcare Update

McGuireWoods LLP on 3/8/2016

This Week: The President took a victory lap in Wisconsin, announcing that 20 million people have gained health insurance through the Affordable Care Act... That figure includes people newly covered through insurance...more

Washington Healthcare Update

McGuireWoods LLP on 2/9/2016

This Week: Congress and the administration focus on the opioid addiction epidemic... Override of the president’s veto of legislation that would have repealed the Affordable Care Act fails, to no one’s surprise... Senate...more

Washington Healthcare Update

McGuireWoods LLP on 2/2/2016

This Week: Because of the Blizzard of 2016—also known as “Snowzilla”—in Washington, D.C., and other parts of the East Coast, this is a combined issue... The House of Representatives opted not to come back to town until next...more

Health Update - September 2015

Manatt, Phelps & Phillips, LLP on 9/25/2015

Latest Healthcare False Claims Act Roundup and Top 3 Best Practices to Reduce Exposure - As the legal landscape in healthcare becomes increasingly complex, healthcare companies that receive federal program funds face...more

Washington Healthcare Update

McGuireWoods LLP on 9/15/2015

This Week: House Energy and Commerce Subcommittee Holds Hearing on Legislation to Strengthen Medicaid Program Integrity and Fraud Controls... Bipartisan Senate Bill Introduced to Stop Anti-Competitive “Pay-For-Delay”...more

Health Update - July 2015

Manatt, Phelps & Phillips, LLP on 7/23/2015

Lessons From the Frontlines: Strategies for Supporting Informed Consumer Decision-Making in the Health Insurance Marketplace - Editor's Note: As marketplaces prepare for the third open enrollment period, consumers are...more

Lack of Materiality as a Defense in False Claims Act Cases

Arnall Golden Gregory LLP on 7/22/2015

The False Claims Act (the “Act”) imposes liability on those who “’knowingly’ present, or cause to be presented, ‘a false or fraudulent claim for payment or approval’” to the government. Persons who act in “deliberate...more

Blog: Litigation Round-Up: Some Recent Drug & Device Settlements, Investigations, Inquiries

Cooley LLP on 10/27/2014

Settlements - Pharmaceutical company Organon Inc. agreed to pay $31 million to settle federal and state allegations that it underpaid Medicaid drug rebates, provided kickbacks to nursing home pharmacy companies,...more

False claims by any other name: Medtronic and Omnicare cases illustrate the interplay between the False Claims Act and other...

Saul Ewing LLP on 7/16/2014

- Government allegations of Medtronic’s alleged incentives to physicians for prescribing its medical devices lead company, while denying wrongdoing, to settle False Claims Act suit predicated on Anti-Kickback Statute. ...more

Medicaid › Food and Drug Administration (FDA) › Department of Justice (DOJ)

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