Health Care Enforcement & Investigations
Viewpoints
Filter by:
DOJ Announces it is Designing a Whistleblower Rewards Program
March 18, 2024 | Blog | By Eoin Beirne, Karen Lovitch , Brian Dunphy, Nick A. LaPalme
In early March 2024 at the American Bar Association’s 39th National Institute on White Collar Crime, Deputy Attorney General (DAG) Lisa Monaco’s keynote remarks previewed the development of new and significant Department of Justice (DOJ or the Department) policy initiatives. Her speech reemphasized many of DOJ’s key themes throughout the current administration, including individual accountability, the importance of strong corporate compliance programs, incentivizing voluntary self-disclosure of misconduct, and adapting to keep up with disruptive technologies such as artificial intelligence.
Read more
Health Law Diagnosed – A Discussion on the Regulatory Requirements for LDTs
March 7, 2024 | Podcast | By Bridgette Keller, Joanne Hawana , Benjamin Zegarelli
In this episode of Health Law Diagnosed, host Bridgette Keller is joined by Mintz Health Law attorneys Joanne Hawana and Benjamin Zegarelli to discuss the FDA’s long-awaited proposed rules that actively regulate laboratory developed tests (LDTs).
Read more
FTC Hosts Panel and Launches Public Inquiry with DOJ and HHS on Private Equity and Health Care
March 6, 2024 | Advisory | By Karen Lovitch , Bruce Sokler, Joseph Miller , Raj Gambhir
EnforceMintz — Health Care Enforcement Trends & 2024 Outlook
February 12, 2024 | Blog
Keeping pace with the ever-evolving landscape of health care enforcement can prove challenging. In the latest EnforceMintz newsletter, Mintz’s Health Care Enforcement Defense practice group highlights emerging enforcement trends, developments in FCA investigations, and provides predictions for 2024, offering helpful guidance through the complexities of health care enforcement.
Read more
EnforceMintz — DOJ and OIG Guidance Emphasizes the Importance of a Robust and Dynamic Compliance Program
February 8, 2024 | Blog | By Cory S. Flashner, Samantha Kingsbury, Nick A. LaPalme
In 2023, the DOJ amplified compliance-related incentives for companies under criminal investigation (including health care companies), while the OIG has substantially revised and modernized previously issued compliance guidance and resources applicable to health care companies and providers.
Read more
EnforceMintz — DOJ’s Limited Use of NPAs and DPAs in Criminal Health Care Investigations
February 8, 2024| Blog|
EnforceMintz — Tech Corner: Q&A with Mintz’s E-Discovery Pro Regarding Artificial Intelligence
February 8, 2024 | Blog | By Samantha Kingsbury, John Koss, Trust D. Kupupika
This Q&A with John Koss, Managing Director of Mintz’s E-Data Consulting Group, delves into the work of the group along with the benefits, challenges, and emerging issues related to using AI in e-discovery.
Read more
EnforceMintz — Government Scrutiny of Medicare Advantage Organizations Expected to Continue in 2024
February 8, 2024 | Blog | By Brian Dunphy, Nicole Henry
Enforcement against Medicare Advantage Organizations continues to be a top priority for the DOJ and HHS’s Office of Inspector General as the number of Medicare Advantage enrollees continued to rise in 2023.
Read more
EnforceMintz — Tele-Fraud Enforcement in 2023 Remained Focused on Same Schemes as Years Past
February 8, 2024 | Blog | By Samantha Kingsbury
Government enforcement activities focused on tele-fraudsters remained active in 2023, with most enforcement actions focusing on fraud schemes involving medically unnecessary durable medical equipment or genetic testing, or both.
Read more
EnforceMintz — DOJ’s Efforts in 2023 to Incentivize Voluntary Self-Disclosure
February 8, 2024 | Blog | By Eoin Beirne, Nick A. LaPalme, Karen Lovitch
In 2023, DOJ announced significant updates to the Criminal Division’s Corporate Enforcement Policy, the agency’s Voluntary Self-Disclosure Policy for corporate criminal enforcement, and a new safe harbor for voluntary self-disclosures made in connection with M&A deals, all aimed at incentivizing companies to self-disclose their misconduct.
Read more
EnforceMintz — A 2023 Legislative Push to Address AI in Health Care Will Continue in 2024
February 8, 2024 | Blog | By Daniel Cody, Brian Dunphy, Samantha Kingsbury
Since May 2023, federal legislators have introduced more than 50 bills focused on issues related to AI technologies, with patient privacy, the role of clinicians, and health equity emerging as areas of focus. In addition, the Biden administration released an Executive Order focused on promoting AI safety in October 2023.
Read more
EnforceMintz — Some of 2023’s Largest FCA Resolutions Involved Stark Law Allegations
February 8, 2024| Blog|
EnforceMintz — 2023 Brings Uptick in Cybersecurity Enforcement, Insight Into Potential Risks
February 8, 2024 | Blog | By Samantha Kingsbury
An uptick in DOJ cybersecurity enforcement in 2023, includes two FCA settlements, an unsealed qui tam complaint, and significant regulatory activity that could pose future enforcement risk.
Read more
EnforceMintz — COVID-19 Fraud Enforcement Unlikely to Slow Down in 2024
February 8, 2024| Blog|
EnforceMintz — DOJ’s Continued Focus on Individual Accountability
February 8, 2024| Blog|
EnforceMintz — Artificial Intelligence and False Claims Act Enforcement
February 8, 2024 | Blog | By Brian Dunphy, Samantha Kingsbury
Health care companies using algorithms and AI applications face increased compliance risks. Previous technology-related enforcement suggests how relators and enforcement agencies might use AI to detect potential fraud and develop allegations based on how the technology is being used.
Read more
EnforceMintz — Practical Lessons Learned from FCA Litigation in 2023
February 8, 2024| Blog|
EnforceMintz — Despite Few Enforcement Actions in 2023, PE Investment in Health Care Remains a Hot Topic
February 8, 2024 | Blog | By Grady Campion, Karen Lovitch
After growing significantly over the last decade, private equity health care deal activity nevertheless remained robust last year, with an estimated deal volume of about $29 billion in North America.
Read more
Challenge to False Claims Act Qui Tam Provisions Fails in an Initial Attempt to Revive Long-Dormant Arguments as to Constitutionality Under Article II
December 7, 2023 | Blog | By Kevin McGinty, Keshav Ahuja
This July, we detailed the Supreme Court’s surprising revival in United States ex rel. Polansky v. Exec. Health Resources, No. 21-1052 (S. Ct. June. 16, 2023), of the question of whether the qui tam provisions of the False Claims Act (“FCA”), see 31 U.S.C. § 3730(b)(1), violate the Executive Branch’s exclusive grant of authority under Article II of the United States Constitution. In Polansky, a lengthy dissent by Justice Thomas questioned whether the False Claims Act qui tam provisions violated the Appointments Clause and Take Care Clause of Article II of the United States Constitution, arguments that had been endorsed by the Department of Justice (“DOJ”) in the 1989, though ultimately repudiated by DOJ just seven years later. A concurrence by Justice Kavanagh, joined by Justice Barrett, stated that “the Court should consider the competing arguments on the Article II issue in an appropriate case.” Shortly after Polansky was decided, a defendant in a declined qui tam case pending in the United States District Court for the Northern District of Alabama accepted Justice Kavanagh’s invitation, and moved to dismiss on Article II grounds. In a decision entered in November, the District Court rejected that challenge.
Read more
HHS Proposes Appropriate Disincentives for Health Care Providers That Commit Information Blocking
November 6, 2023 | Blog | By Pat Ouellette, Rachel Yount
In coordination with the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS) and Office of the National Coordinator for Health Information Technology (ONC) proposed a much-anticipated framework to establish and manage “appropriate disincentives” for health care providers under the Information Blocking Rules. As described in more detail in the blog post, the proposed rule (Appropriate Disincentives Proposed Rule) includes proposed disincentives for (i) hospitals and critical access hospitals (CAHs) participating in the Medicare Promoting Interoperability Program; health care providers eligible for Merit-Based Incentive Payment System (MIPS) adjustments; and health care providers participating in the Medicare Shared Savings Program (MSSP).
Read more
Explore Other Viewpoints:
- Antitrust
- Appellate
- Arbitration, Mediation & Alternate Dispute Resolution
- Artificial Intelligence
- Awards
- Bankruptcy & Restructuring
- California Land Use
- Class Action
- Complex Commercial Litigation
- Construction
- Consumer Product Safety
- Cross-Border Asset Recovery
- Debt Financing
- Direct Investing (M&A)
- Diversity
- EB-5 Financing
- Education & Nonprofits
- Employment, Labor & Benefits
- Energy & Sustainability
- Environmental Enforcement Defense
- Environmental Law
- FDA Regulatory
- Federal Circuit Appeals
- Financial Institution Litigation
- Government Law
- Growth Equity
- Health Care
- Health Care Compliance, Fraud and Abuse, & Regulatory Counseling
- Health Care Enforcement & Investigations
- Health Care Transactions
- Health Information Privacy & Security
- IP Due Diligence
- IPRs & Other Post Grant Proceedings
- Immigration
- Insolvency & Creditor Rights Litigation
- Institutional Investor Class Action Recovery
- Insurance & Financial Services
- Insurance Consulting & Risk Management
- Insurance and Reinsurance Problem-Solving & Dispute Resolution
- Intellectual Property
- Investment Funds
- Israel
- Licensing & Technology Transactions
- Life Sciences
- Litigation & Investigations
- M&A Litigation
- ML Strategies
- Medicare, Medicaid and Commercial Coverage & Reimbursement
- Mergers & Acquisitions
- Patent Litigation
- Patent Prosecution & Strategic Counseling
- Portfolio Companies
- Privacy & Cybersecurity
- Private Client
- Private Equity
- Pro Bono
- Products Liability & Complex Tort
- Projects & Infrastructure
- Public Finance
- Real Estate Litigation
- Real Estate Transactions
- Real Estate, Construction & Infrastructure
- Retail & Consumer Products
- Securities & Capital Markets
- Securities Litigation
- Special Purpose Acquisition Company (SPACs)
- Sports & Entertainment
- Strategic IP Monetization & Licensing
- Tax
- Technology
- Technology, Communications & Media
- Trade Secrets
- Trademark & Copyright
- Trademark Litigation
- Venture Capital & Emerging Companies
- White Collar Defense & Government Investigations
- Women's Health and Technology