False Claims Act Insights - Powerful, But Not All-Powerful: CIDs in FCA Litigation
Ep. 3 - The Art of Parallel Investigations (Part 2)
False Claims Act Insights - Reality Checks: How to Approach Healthcare Transactions Without Triggering FCA Liability
Podcast - Discussing a DOJ Lawsuit Under the Civil-Fraud Initiative
False Claims Act Insights - Are the FCA’s Qui Tam Provisions Unconstitutional? One Federal Judge Says “Yes"
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?
The Centers for Medicare & Medicaid Services (CMS) released highly anticipated updates this month to the Medicare regulations interpreting the federal 60-day overpayment refund requirement (the Overpayment Statute). The...more
After years in the making, on October 15, 2024, the U.S. Department of Defense (DoD) published its final rule to establish the Cybersecurity Maturity Model Certification (CMMC) Program, amending Title 32 of the Code of...more
On Friday, November 1, 2024, the Center for Medicare & Medicaid Services (CMS) issued the display copy of the final rule interpreting the 60-day Refund Rule for Medicare Parts A/B (Traditional Medicare) and C/D (Medicare...more
On September 17, 2024, the Office of Research Integrity (ORI) issued a final rule adopting changes to federal regulations governing research misconduct involving federally funded research (Final Rule). The regulations have...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more
In the context of Medicare Advantage (“MA”) reform initiatives, we previously addressed the Centers for Medicare & Medicaid Services’ (“CMS”) December 27, 2022 proposal to amend its regulations set forth at 42 C.F.R. §...more
On April 22, 2024, the Office for Civil Rights (OCR) for the United States Department of Health and Human Services issued a Final Rule amending the Privacy Rule of the Health Insurance Portability and Accountability Act...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more
On April 22, 2024, the U.S. government issued a final rule ("Rule") to restructure and update the Federal Acquisition Regulation ("FAR") to implement a requirement for agencies to procure sustainable products and services to...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for November 2023. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new General...more
In addition to prohibiting the flow-down of non-mandatory FAR/DFARS clauses (which we talk about here), the Department of Defense (“DOD”) Final Rule in connection with the Defense Federal Acquisition Regulation Supplement...more
On June 27, 2023, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) released its final rule (“Final Rule”) implementing penalties for information blocking....more
On April 5, the Centers for Medicare & Medicaid Services (“CMS”) released the 2024 Medicare Advantage and Prescription Drug Benefit Programs Final Rule (“Final Rule”), which will be codified at 42 C.F.R. Parts 417, 422, 423,...more
Many providers are not familiar with their obligations under the “60 Day Rule,” also known as Reverse False Claims liability, which can cause significant financial harm if providers fail to comply with these obligations....more
On January 11, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued, without an opportunity for public notice and comment, a Final Rule, amending its internal process for...more
Responding to industry stakeholder sentiment, the Office of Inspector General (OIG) for the U.S. Department of Health & Human Services (HHS) recently issued an unexpected final rule that, effective February 10, 2022, will...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
On August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, marking the end of an effort FDA began in 2015. While the...more
Individual Prosecutions Down But Corporate Resolutions Steady for DOJ’s Fraud Section in 2020, with More in the Pipeline - The Department of Justice’s (“DOJ”) Fraud Section recently released a year-in-review report that...more
Fresenius to defend itself from FCA suit following whistleblower allegations - A former employee alleges Fresenius engaged in arrangements with hospitals and nephrologists to ensure patient referrals to its dialysis...more
On December 21, 2020, the Department of Defense (DoD) Office of the Undersecretary of Defense for Intelligence & Security published a Final Rule codifying the National Industrial Security Program Operating Manual...more
Calls for Significant Changes To Federal Domestic Preference Policy, Waivers, and Buy American Eligibility - President Biden signed an executive order (order or EO) on January 25, 2021, to direct more spending of the...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
HHS Announces Final Rules Amending Stark Law Regulations and Anti-Kickback Statute - On November 20, 2020, the Centers for Medicare and Medicaid Services and the Department of Health and Human Services (HHS) published...more
The Trump Administration recently announced two final rules that implement policy objectives to lower drug prices by tying certain Medicare Part B payments to prices paid by other countries and by replacing an anti-kickback...more