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CMS Releases Part Two of Guidance for the Inflation Reduction Act’s Medicare Prescription Payment Plan
February 27, 2024 | Blog | By Tara E. Dwyer, Lauren Moldawer, Madison Castle
On February 15, 2024, the Centers for Medicare and Medicaid Services (CMS) released the Medicare Prescription Payment Plan Draft Part Two Guidance (Part Two Guidance) as part of the Inflation Reduction Act’s (IRA) efforts to tackle high prescription drug costs. The Medicare Prescription Payment Part Plan (the Program), which was previously referred to as the “OOP Smoothing Program”, was established as part of the IRA and requires Part D plans (PDPs) to offer their members an option to pay for out-of-pocket (OOP) prescription drug costs in monthly capped payments, as opposed to all at once, at a pharmacy. Meaning, for members who opt-in to the Program, they will pay $0 at the pharmacy and the PDP must pay the pharmacy the full cost-sharing amount of the drug and then bill the member the amount of the cost-sharing over the remainder of the calendar year.
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California’s Health Care Transactions Review Law: Preparing for What Comes Next
February 26, 2024 | Blog | By Kathryn Edgerton, Deborah Daccord, Karen Lovitch
California’s health omnibus trailer bill SB-184 and the final cost and market impact review (CMIR) regulations (CMIR Regulations), which went into effect on December 18, 2023, have ushered in a significant change in California’s health care regulatory landscape with the creation of the Office of Health Care Affordability (OHCA). On January 2, 2024, OHCA began accepting notices of covered transactions through its notice of material change transaction submission portal.
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Mintz IRA Update — Second Edition: Q1 2024
February 21, 2024 | Blog | By Rachel A. Alexander, Theresa Carnegie, Tara E. Dwyer, Madison Castle, Mitchell Clough, Xavier Hardy, Stephnie John, Bridgette Keller, Abdie Santiago, Hassan Shaikh
Mintz IRA Update — Demystifying the IRA’s Small Biotech Exception
February 21, 2024 | Blog | By Xavier Hardy, Abdie Santiago
New Mexico Latest State to Expand Medicaid Behavioral Health Program, Add Mobile Crisis Intervention Program
February 21, 2024 | Blog | By Pat Ouellette, Kathryn Edgerton
New Mexico recently became the latest state to receive Centers for Medicare & Medicaid Services (CMS) approval to expand the state’s behavioral health service offerings through mobile crisis intervention teams. Under its new state plan amendment, among other items, New Mexico will make available mobile (i.e., outside of a hospital or other facility setting) crisis and mobile response and stabilization services for individuals at the location in which they are experiencing a crisis, 24 hours a day, 7 days a week, 365 days per year. Mobile crisis services include stabilization of the person in crisis, prevention of further deterioration, and provision of immediate treatment and intervention but may also include telephonic follow-up interventions, such as additional intervention and de-escalation services and coordination with other supports and community partners, for up to 72 hours after the initial mobile response. New Mexico also will offer children’s mobile response and stabilization services (MRSS), which are mobile crisis services but specific to child, youth, and families and include up to 56 days of stabilization services.
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Mintz IRA Update — The IRA in 2024: The Medicare Drug Price Negotiation Program in Full Swing and Other Developments
February 21, 2024 | Blog | By Stephnie John
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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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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