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Mintz IRA Update — Biden Administration Proposes Allowing Agencies to 'March-In' to Control Rising Drug Prices
February 21, 2024 | Blog | By Madison Castle, Abdie Santiago, Stephnie John
Mintz IRA Update — Legal Challenges to the Medicare Drug Price Negotiation Program Continue
February 21, 2024 | Blog | By Xavier Hardy, Matthew Tikhonovsky
Mintz IRA Update — Removal of AMP-Cap on Medicaid Rebates Causes Insulin Price Decrease
February 21, 2024 | Blog | By Bridgette Keller, Madison Castle, Abdie Santiago
Quality System Harmonization Is Here, But with Small Benefit to Device Industry
February 15, 2024 | Blog | By Benjamin Zegarelli
After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820 with the internationally accepted standard for medical device quality management systems established by the International Organization for Standardization, the 2016 edition of ISO 13485, “Medical devices - Quality management systems - Requirements for regulatory purposes” (known as “ISO 13485:2016”). We previously mentioned back in January 2021 that FDA had plans to initiate notice-and-comment rulemaking to describe the harmonization process sometime in 2021, plans that the agency had been discussing for years prior. FDA finally published a Notice of Proposed Rulemaking for the harmonization in February 2022 and, then, following the agency’s consideration of stakeholders’ submitted comments, it issued the Final Rule on February 2, 2024.
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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.
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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.
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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.
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EnforceMintz — Some of 2023’s Largest FCA Resolutions Involved Stark Law Allegations
February 8, 2024 | Blog | By Grady Campion, Daniel Cody, Laurence Freedman, Laura E. Martin
In the past year, DOJ obtained some of its largest recoveries in cases where violations of the Stark Law, which bars physicians from profiting from self-referrals for certain services payable by Medicare or Medicaid, served as a predicate offense for FCA claims. These included cases against Community Health Network, Covenant Healthcare System, Cardiac Imaging, and Steward Health entities.
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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.
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EnforceMintz — COVID-19 Fraud Enforcement Unlikely to Slow Down in 2024
February 8, 2024 | Blog | By Laurence Freedman, Jane Haviland
The government continued to dedicate enormous resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs in 2023. In addition to civil False Claims Act settlements, there were a number of criminal enforcement matters, including some involving politicians, government employees, and those with connections to gangs and transnational crime networks.
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EnforceMintz — DOJ’s Continued Focus on Individual Accountability
February 8, 2024 | Blog | By Grady Campion, Daniel Cody, Laurence Freedman, Laura E. Martin
Several case dispositions from this past year, both criminal and civil, reaffirm DOJ’s policy of ensuring individual accountability in resolving allegations of wrongdoing and underscore the importance of considering that issue in the resolution of any FCA case.
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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.
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EnforceMintz — Practical Lessons Learned from FCA Litigation in 2023
February 8, 2024 | Blog | By Grady Campion, Daniel Cody, Laurence Freedman, Laura E. Martin
In 2023, the Supreme Court and the US Courts of Appeals published a number of significant decisions involving FCA issues with implications for health care and life science entities, including a deepening circuit split on the causation standard applicable to FCA cases based on theories under the Anti-Kickback Statute.
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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.
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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.
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EnforceMintz — DOJ’s Limited Use of NPAs and DPAs in Criminal Health Care Investigations
February 8, 2024 | Blog | By Grady Campion, Daniel Cody, Laurence Freedman, Laura E. Martin
Despite the DOJ Criminal Division’s January 2023 revisions to its Corporate Enforcement Policy defining the criteria for declining to prosecute a criminal case, based on the two case examples from this past year, it is unclear how often the DOJ will actually put that policy into practice and decline or defer prosecution.
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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.
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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.
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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.
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CMS Announces New Model for the Delivery of Integrated Behavioral and Physical Health Care
February 5, 2024| Blog|
Viewpoint Editors
Karen S. Lovitch
Chair, Health Law Practice & Co-Chair, Health Care Enforcement Defense Practice
Joanne S. Hawana
Member
Rachel E. Yount
Of Counsel
Pat G. Ouellette
Associate
Stephnie A. John
Associate
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