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
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
The Centers for Medicare & Medicaid Services (CMS) proposed a rule late last year that would impose standards on healthcare providers and suppliers to report and return overpayments from Medicare that mirror aspects of the...more
Litigation involving drug price reporting under the Medicaid Drug Rebate Program (MDRP) has been very active in 2022. Most recently, on August 3, 2022, an Illinois federal jury levied a $61 million verdict against Eli...more
In a split decision issued January 25, 2022, the Fourth Circuit strongly endorsed a defense to False Claims Act liability for entities that submit claims to the government in today’s complex regulatory environment, finding:...more
On June 29, 2021, the Department of Justice (DOJ) announced a settlement with California skilled nursing facility operator Plum Healthcare Group LLC and facility Azalea Holdings LLC dba McKinley Park Care Center (Plum) to...more
Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers About the Enforcement in Life Sciences Series Recent settlements between the U.S. Department of...more
On Sept. 27, 2019, the Securities and Exchange Commission (SEC) announced that Mylan N.V., a global pharma company that manufactures and sells EpiPen, which is used to treat serious allergic reactions, agreed to pay $30...more
The 60-Day Overpayment Refund Rule (60-Day Rule) was enacted as Section 6402 of the Affordable Care Act (ACA) on March 23, 2010. ...more
The U.S. District Court for the District of Columbia handed down a major victory to Medicare Advantage issuers on September 7, 2018, vacating a 2014 CMS regulation relating to Medicare Advantage overpayments. ...more
For value-based payments, encounter data[1] provides valuable information in much the same way that claims data does for fee-for-service arrangements. With the growing prevalence of value-based payments, especially in the...more
The District Court for the Middle District of Tennessee held on June 22, 2017, that the timing requirements related to a physician's certification of need for home health services were not "material" to the Centers for...more
The Affordable Care Act (sometimes referred to as Obamacare) included a requirement for providers to report and return all Medicare and Medicaid overpayments within 60 days of identification. Although this requirement has...more
On February 12, 2016, the Centers for Medicare & Medicaid Services (“CMS”) published a final rule that explains the requirements for providers and suppliers reporting and returning overpayments under Medicare Parts A & B (the...more
The Centers for Medicare & Medicaid Services (CMS) published the Reporting and Returning of Overpayments Final Rule (Final Rule) on February 12, 2016. The Final Rule implements Section 6402(a) of the Affordable Care Act,...more
The Centers for Medicare and Medicaid Services (“CMS”) has clarified the reporting requirements and lookback period for overpayments from Medicare Parts A and B in Final Rule 6037 (“Final Rule”), issued by CMS on February 12,...more
After more than four years since the issuance of its Proposed Rule, the Centers for Medicare & Medicaid Services (CMS) will implement its Final Rule on the reporting and return of Medicare Parts A and B overpayments,...more
The Department of Health and Human Services’ (HHS) Center for Medicare and Medicaid Services (CMS) published its final rule on Friday, February 12, 2016. The final rule clarifies two key sections of the often described 60-Day...more
Medicare Part A and B providers and suppliers should take note of new regulations recently issued by the Centers for Medicare & Medicaid Services that implement the Affordable Care Act’s 60-day rule on reporting and returning...more
The Centers for Medicare and Medicaid Services (CMS) recently issued its final rule for Reporting and Returning of Overpayments (Final Rule). The Final Rule implements section 1128J(d) of the Social Security Act, which...more
On February 12, 2016, CMS published a final rule addressing compliance with Section 1128J(d) of the Social Security Act. Section 1128J(d), which was added when the Affordable Care Act was enacted on March 23, 2010, imposes a...more
On February 12, 2016, the Centers for Medicare & Medicaid Services (CMS) published a long-awaited final rule (Final Rule) implementing the Affordable Care Act’s (ACA’s) statutory requirement that certain overpayments be...more
On February 12, 2016, the Centers for Medicare & Medicaid Services (CMS) released a final rule (Final Rule) interpreting the application of Section 1128J(d) of the Social Security Act (the 60-Day Rule) to over payments...more
The Centers for Medicare & Medicaid Services (CMS) published the Reporting and Returning of Overpayments Final Rule (Final Rule) on February 12, 2016. The Final Rule implements section 6402(a) of the Affordable Care Act which...more
On February 12, 2016, the Centers for Medicare and Medicaid Services (CMS) published its long-awaited final rule (the “Final Rule”) governing the requirement that healthcare providers report and return Medicare overpayments...more
On February 12, 2016, the Centers for Medicare & Medicaid Services (CMS) published its long-anticipated Final Rule implementing Section 6402(a) of the Patient Protection and Affordable Care Act (ACA) (section 1128J(d) of the...more