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Manufacturers Should Carefully Evaluate OIG’s Approval of Medicare Cost Sharing Subsidies in Clinical Trials

At the end of last year, the US Department of Health and Human Services Office of Inspector General (OIG) issued an Advisory Opinion (AO 23-11, the Opinion) in which OIG approved an arrangement where a medical device...more

CMS Publishes Final Rule for Minimum Staffing Standards for Long-Term Care Facilities

The Centers for Medicare & Medicaid Services (CMS) published its Final Rule today to implement a minimum staffing “floor” for nursing homes in the United States, as first announced on April 22. The Final Rule, which as...more

Mass. USAO Hints at Healthcare Fraud Enforcement Focus in Rare Disease Space at White Collar Crime Conference

The Boston Bar Association hosted its fifth annual White Collar Crime Conference on May 2, 2024, featuring prosecutors from the US Attorney’s Office for the District of Massachusetts (the Office) and the Office of the...more

Show Me the Data: What Does DOJ’s Data-Driven Investigative Focus Mean for Healthcare Stakeholders?

As noted in our recent LawFlash, the US Department of Justice’s (DOJ’s) COVID-19 Fraud Enforcement Task Force (CFETF) recently released its annual compilation report of its efforts to combat fraud related to pandemic relief...more

Once Again #1: Health Care Fraud Leads DOJ False Claims Act Recoveries in 2024

The US Department of Justice (DOJ) Civil Division released its annual fraud statistics on February 22, highlighted by False Claims Act (FCA) settlements and judgments exceeding $2.68 billion in fiscal year 2023. DOJ released...more

Trending in 2024: What Does the HCFAC Report Signal About Federal Enforcement Mechanisms?

The Health Care Fraud and Abuse Control Program (HCFAC), an annual report jointly issued by the US Department of Justice (DOJ) and Department of Health and Human Services (HHS), can be helpful in predicting DOJ and HHS...more

DOJ Offers Encouragement for Organizations Looking Into M&A Deals

At a recent Food and Drug Law Institute (FDLI) conference, Arun Rao, Deputy Assistant Attorney General for the US Department of Justice’s (DOJ’s) Consumer Protection Branch (CPB), reiterated DOJ’s “Safe Harbor Policy” with...more

CMS Announces Nursing Home Staffing Standards and Accountability Initiative

The Biden administration recently announced its much-anticipated proposed rule for implementing a minimum staffing “floor” for nursing homes in the United States and further launched a nursing home accountability initiative....more

False Claims Act Breakups Are Harder to Do in the District of Massachusetts

As we at Morgan Lewis pride ourselves on excellent client service, we feel it is our duty to provide critical dispatches from the romantic world of healthcare fraud. Specifically, we want to highlight developments in the...more

White Collar Crime Conference Talks Healthcare Fraud

The Boston Bar Association held its annual White Collar Crime Conference on May 4, 2023, featuring lawyers from the defense and plaintiffs’ bar and current and former prosecutors from the US Attorney’s Office for the District...more

How the End of the PHE Will Impact the Healthcare Industry

The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of...more

Long-Term Care Facilities: What to Expect When the COVID-19 PHE Ends

Key provisions that provided flexibility to long-term care providers and helped alleviate administrative burdens will expire May 11, 2023. Long-term care facilities (LTCs), skilled nursing facilities (SNF), and nursing...more

DOJ Announces New COVID-19 Fraud Takedown – But Will It Expand Enforcement to More Complex Schemes?

Fraud stemming from the COVID-19 pandemic continues to be a criminal enforcement priority for the US Department of Justice (DOJ). On April 20, DOJ announced a new round of criminal charges against 21 defendants that stem from...more

DOJ Discusses Enforcement, Reiterates Biden-Harris Anti-Corruption Commitment at ACI FCPA Conference

This LawFlash summarizes key takeaways from the American Conference Institute’s (ACI’s) 38th International Conference on the Foreign Corrupt Practices Act (FCPA), where top government officials offered insight and...more

2018 Year in Review: Select SEC and FINRA Developments and Enforcement Cases

The Morgan Lewis Year in Review highlights key US Securities and Exchange Commission (the SEC or the Commission) and Financial Industry Regulatory Authority (FINRA) enforcement developments and cases regarding broker-dealers,...more

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