AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
False Claims Act Insights - Physician, Refer Thyself: How Stark Law and FCA Intersect
2022 Resolutions: What Healthcare Practices Need To Tackle In the New Year
Goran Musinovic on Healthcare Real Estate Compliance
Podcast: CMS and OIG Final Rules for Innovating Your Value-Based Payment Program - Diagnosing Health Care
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Anti Kickback and Stark Law Enforcement and Compliance Issues
With the first half of 2025 in the rearview mirror, the government’s continued focus on False Claims Act (FCA) enforcement shows no signs of slowing. In fact, the Department of Justice recently announced the results of a...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2025, including the rollout of a new Centers for Medicare & Medicaid Services (CMS) strategy to expand and enhance Medicare...more
The Centers for Medicare and Medicaid Services (CMS) issued CMS Advisory Opinion No. CMS-AO-2025-1 on February 26, 2025, blessing the relocation of a physician-owned hospital. The hospital planned to relocate eight miles from...more
On Feb. 26, 2025, McGuireWoods successfully assisted a physician-owned hospital in obtaining a favorable advisory opinion from the Centers for Medicare & Medicaid Services (CMS) regarding its proposal to relocate the entire...more
The Centers for Medicare & Medicaid Services (CMS) recently released data on its 2024 settlements of voluntary self-disclosures related to past violations or potential violations of the physician self-referral law (the Stark...more
In 2024, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) provided useful insights to the healthcare industry regarding how it approaches various fraud and abuse issues in an...more
The Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics on January 15, 2025, announcing that it had recovered in excess of $2.9 billion from FCA resolutions during Fiscal Year (FY)...more
Fraud related to hospital services – both inpatient and outpatient – has led to over $511 million in damages and hundreds of millions of dollars in False Claims Act (FCA) settlements over the past 15 years. The ER has been...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for December 2024. We discuss several civil and criminal enforcement actions pertaining to healthcare fraud and abuse authorities,...more
On 15 January 2025, the US Department of Justice (DOJ) published its report (Report) announcing civil recoveries under the False Claims Act (FCA) for Fiscal Year (FY) 2024. The recoveries for FY 2024 exceeded US$2.9 billion,...more
Healthcare fraud enforcement continues to be a top priority for federal authorities, with Stark Law violations remaining under particular scrutiny. The complex nature of physician self-referral regulations, combined with...more
In 2024, the Department of Justice (DOJ) resolved several noteworthy False Claims Act (FCA) cases against hospitals and health systems. In particular, DOJ obtained a number of large recoveries in cases where Stark Law and...more
On January 15, the Department of Justice (DOJ) released its annual report on civil fraud recoveries for FY2024 along with a press release highlighting DOJ’s civil enforcement efforts....more
Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions - In a brief filed earlier this week, the US federal government has urged the Eleventh Circuit Court of Appeals to uphold the...more
A recently issued federal court opinion confirmed that certain pre-COVID era prescribing restrictions are back in place. In July 2023, a nonprofit advocacy group, Community Oncology Alliance, filed suit against the U.S....more
As a general rule, healthcare employers are required to pay employed physicians and other contracted providers fair market value (FMV) for their services, but many employers do not understand relevant regulatory standards. ...more
Engaging in management and investor conversations about maintaining and growing a business is critical, no matter the industry. Whether you’re discussing normal business sustainability, organic growth, or contemplating a...more
Precision Lens Pays $12 Million to Resolve FCA and AKS Violations - Late last week, Precision Lens and the estate of its former principal agreed to pay $12 million to resolve allegations regarding violations of the False...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...more
Welcome to the Summer 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and...more
Florida Lab Owner Agrees to Pay Over $27 Million to Resolve Three Whistleblower Lawsuits - Daniel Hurt, the prior owner and operator of Fountain Health Services LLC, Verify Health, Landmark Diagnostics LLC, First Choice...more
Leading health authorities have increasingly emphasized how non-medical factors such as socioeconomic status, education, employment, housing, food security, and community support have an outsized impact on health outcomes. By...more
Although often well-intentioned, offering free or discounted items or services to patients (e.g., gifts, rewards, writing off copays, free screening exams, free supplies, etc.) may violate federal and state laws governing...more
The Physician Self-Referral Law — known as the “Stark Law” — broadly prohibits physicians from profiting from self-referrals for “designated health services” (DHS) payable by Medicare or Medicaid. For example, the Stark Law...more
From 1998-2008, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published compliance program guidelines for various industries in the Federal Register....more