Podcast - Cybersecurity Roundup: Analyzing New and Proposed Rules for Contractors
AGG Talks: Women in Tech Law Podcast - Episode 3: Cybersecurity and FCA Compliance: Essential Insights for Tech Leaders
False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
False Claims Act Insights - If Everything Matters, Nothing Does: Parsing Materiality in FCA Disputes
False Claims Act Insights - Assessing the Fallout from a Thermonuclear FCA Verdict
False Claims Act Insights - Eureka! Government Investigators Seek Out Research Misconduct
Common Scenarios Triggering False Claims Act Violations, Part 3: Claims and Investigations
Common Scenarios Triggering False Claims Act Violations, Part 1: Gov. Contracts and Cybersecurity
False Claims Act Insights - Physician, Refer Thyself: How Stark Law and FCA Intersect
False Claims Act Insights - The Art and Science of Corporate Compliance in Managing FCA Risk
The Latest on Healthcare Enforcement
False Claims Act Insights - Railroaded! How to Approach the Twin Tracks of Parallel Proceedings
FCA Uncovered: Mitigating Risk in the Regulatory Spotlight — Regulatory Oversight Podcast
False Claims Act Insights - Are We Done Here? The Unique Dynamics of FCA Settlements
False Claims Act Insights - Help! I Got a Civil Investigative Demand from DOJ. What Do I Do?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 186: White Collar Crimes in Healthcare with Maynard Nexsen’s White Collar Team
False Claims Act Insights - Think You Know Whistleblowers? Think Again.
PilieroMazza Annual Review What DOJ’s Annual FCA Report Means for Government Contractors
Protecting Our Nation’s Data: Cybersecurity Compliance for Government Contractors
Medical Device Legal News with Sam Bernstein: Episode 19
On August 26, 2024, the United States Attorney’s Office for the District of Montana filed a False Claims Act (FCA) complaint against a Montana oncologist, alleging that the oncologist’s busy schedule led to excessive claims...more
On May 29, 2024, the U.S. Department of Health and Human Services’ Office of Inspector General (HHS OIG) announced a $12 million settlement with Innovasis Inc., a medical device manufacturer, and two of its senior executives...more
The Department of Justice (DOJ) recently filed a complaint against Erlanger Health System (Erlanger), a county-owned public health system, and two of its Tennessee hospitals alleging that the health system systemically...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
In early May 2024, the University of Pittsburgh Medical Center (UPMC) agreed to pay $38 million to resolve a False Claims Act case based on alleged Stark Law violations. The size of the settlement in United States ex rel. J....more
We often work with valuation experts to ensure compensation payments between healthcare organizations and physicians are fair market value and commercially reasonable for purposes of compliance with the Stark Law and the...more
When negotiating physician compensation issues, hospitals frequently rely upon the premise they must pay fair market value compensation in order to comply with the provisions of the Stark Act prohibiting referrals in exchange...more
November 28, 2023 | Legal Update On November 10, 2023, the Office of the Inspector General (OIG) released its widely anticipated General Compliance Program Guidance (GCPG). The OIG had previously announced that it would...more
On the heels of the Sixth Circuit’s recent decision in Martin v. Hathaway, previously discussed on Health Law Observer, a critical issue in that case, i.e., the meaning of the term “remuneration” for purposes of the federal...more
An important threshold question in qui tam cases under the False Claims Act is whether the relator-whistleblower is the original source of the information forming the basis for the claim. This is because qui tam actions under...more
On November 1, 2022, Modernizing Medicine, Inc. (“ModMed”), an electronic health record (“EHR”) technology vendor, entered into a settlement agreement with the Department of Justice (“DOJ”), agreeing to pay $45 million to...more
Learning Objectives: - Impact 2021 Physician Fee Schedule has had/will have on Physician Compensation and Benchmark Data - Impact COVID has had/will have on Physician Compensation - Evolution of Use of Benchmark Data,...more
Each year, the Department of Justice (DOJ) recovers millions of dollars through False Claims Act (FCA) settlements, and 2021 was no exception. Some of the most sizeable or otherwise noteworthy settlements from 2021 were with...more
Our one-day Regional Compliance Conferences provide attendees with a forum to interact with local compliance professionals, share information about your compliance successes and challenges, and create educational...more
Court Rules Prescription Drug Event and Enrollee Encounter Data Are 'Claims for Payment' Under the False Claims Act - US District Judge Noel L. Hillman approved a whistleblower’s request to file a Fourth Amended Complaint...more
For companies looking to monetize their hard-earned innovations in digital health, there is a minefield of potential healthcare enforcement to avoid. As discussed in Part I of this alert, such healthcare enforcement can lead...more
The Situation: Under the federal Physician Self-Referral Law ("Stark Law"), many physician arrangements must meet one or more of the so-called "big three" requirements: that the arrangement be "commercially reasonable," that...more
On November 16, 2020, the Office of Inspector General of the Department of Health and Human Services (OIG) issued a Special Fraud Alert addressing the fraud and abuse risks of speaker programs that are commonplace in the...more
Acute Care Hospital Agrees to Pay $50 Million to Settle Alleged Stark Law and Anti-Kickback Statute Violations - On September 9, 2020, the Department of Justice (“DOJ”) announced that Wheeling Hospital Inc. (“Wheeling...more
For private equity transactions going forward during the COVID-19 crisis, and for those occurring several years after it’s over, private equity investors will need to perform additional due diligence to evaluate whether and...more
The Situation: The isolated transactions exception under the Stark Law has been used by some providers and entities to retroactively protect services arrangements that do not qualify for personal services or market value...more
Part of the Centers for Medicare and Medicaid Services’ (CMS) proposed changes “to modernize and clarify” regulations interpreting the Physician Self-Referral Law (the “Stark Law”), released on October 9, 2019, contain...more
Bingham v. HCA, Inc., a recent Eleventh Circuit case, highlights the centrality of fair market value to Anti-Kickback Statute (AKS) analyses. This decision is significant for several reasons and we expect to see Bingham cited...more
The Centers for Medicare & Medicaid Services (CMS) will be putting hospitals in an untenable position if recent proposed rulemaking is implemented as is. In its proposal for acting on legislation reducing payments to new,...more
The Stark Law was originally enacted by Congress in 1989 as the Ethics in Patient Referrals Act. Initially, it prohibited a physician from referring Medicare beneficiaries to clinical labs in which the physician had an...more