The US Department of Justice, along with several state attorneys general, has issued subpoenas and civil investigative demands to hospitals, physicians, telehealth companies, and pharmaceutical manufacturers engaged in...more
11/5/2025
/ Civil Investigation Demand ,
Department of Justice (DOJ) ,
Gender Discrimination ,
Gender Expression ,
Gender Identity ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Privacy Rule ,
Hospitals ,
LGBTQ ,
Patient Privacy Rights ,
PHI ,
Shield Laws ,
State Attorneys General ,
State Privacy Laws ,
Subpoenas ,
Telehealth ,
Transgender
In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (2025 Cybersecurity Guidance). This...more
11/5/2025
/ Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Medical Devices ,
New Guidance ,
New Legislation ,
Popular ,
Regulatory Requirements ,
Risk Management
Representatives from the defense bar and the healthcare and life sciences industry recently met for the American Health Law Association’s Fraud and Compliance Forum. The conference programming covered an array of topics for...more
10/17/2025
/ Artificial Intelligence ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Health Insurance ,
Healthcare Fraud ,
Innovative Technology ,
Medicaid ,
Medicare Advantage ,
Nursing Homes ,
OIG ,
State and Local Government
The US Department of Justice has proposed legislation to the US Congress that would, if enacted, create a private right of action against healthcare professionals who provide gender-affirming care to children. The proposal...more
9/8/2025
/ Constitutional Challenges ,
Department of Justice (DOJ) ,
Gender Discrimination ,
Gender Expression ,
Gender Identity ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
LGBTQ ,
Minor Children ,
Patient Access ,
Patient Privacy Rights ,
Physicians ,
Private Right of Action ,
Proposed Legislation ,
Statute of Limitations ,
Transgender ,
Trump Administration
The US Department of Justice’s settlement with Illumina, Inc. is a first-of-its-kind involving alleged cybersecurity deficiencies causing violations of the False Claims Act (FCA) based on FDA quality standards. The...more
8/13/2025
/ Cybersecurity ,
Department of Justice (DOJ) ,
Digital Health ,
Enforcement Actions ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Healthcare Fraud ,
Life Sciences ,
Medical Devices ,
Popular ,
Whistleblowers
On August 1, 2025, 16 state attorneys general filed a complaint in federal court in Massachusetts against the US administration seeking a declaratory judgment that President Trump’s January 28, 2025 Executive Order 14187,...more
In a relatively rare move, the US Department of Health and Human Services Office of Inspector General (OIG) recently issued an unfavorable Advisory Opinion (No. 25-08) (Opinion) reinforcing the agency’s expansive view of the...more
The US Court of Appeals for the Seventh Circuit recently issued a decision that has important implications for stakeholders in the durable medical equipment (DME), medical device, and telehealth space as well as future civil...more
On May 10, 2024, the Centers for Medicare and Medicaid Services (CMS) published its Final Rule to implement minimum staffing standards for long-term care (LTC) facilities in the United States. However, as discussed in our...more
Medicare Advantage is the dominant Medicare delivery system, now covering 54% of all Medicare enrollees. With the increase in enrollment and federal spending, however, has come increased scrutiny from enforcement and...more
In United States v. Regeneron Pharmaceuticals Inc., the US Court of Appeals for the First Circuit held that when the government seeks to establish False Claims Act liability under the 2010 amendment to the Anti-Kickback...more
In remarks delivered at the Federal Bar Association’s (FBA) annual Qui Tam Section Conference, Deputy Assistant Attorney General Michael Granston reiterated the US Department of Justice’s (DOJ or the Department) commitment to...more
Patient assistance programs (PAPs) emerged to help patients who lack health insurance or prescription drug coverage obtain critical, and often, life-saving medications. This is especially true for rare disease patients, whose...more
In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more
In honor of Rare Disease Day on February 28, 2025, Morgan Lewis is publishing a series of posts on As Prescribed and Health Law Scan throughout the month of February on issues impacting the rare disease community....more
This report compiles several important developments that shaped the healthcare and life sciences industries in 2024 and spotlights key areas to watch in 2025. Each section addresses either an industry sector within healthcare...more
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
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
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
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
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
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
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
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
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