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FDA Needs a New Approach to AI/ML-Enabled Medical Devices
March 12, 2024 | Blog | By Benjamin Zegarelli
We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the Digital Health Center of Excellence, implementing predetermined change control plans, and issuing various digital health guidances on device software functions, clinical decision support software, cybersecurity, and other topics. In anticipation of FDA’s Artificial Intelligence /Machine Learning (AI/ML) Medical Devices Workshop in October 2021, we posted a brief history of the agency’s regulatory oversight of software through the traditional medical device regulatory framework established in the 1970s, in which we highlighted the numerous challenges associated with such an approach. But now, with the rise of artificial intelligence and machine learning and the proliferation of AI/ML-enabled software throughout the health care industry, FDA is facing enormous challenges using an outdated, procrustean regulatory framework to maintain standards of safety and quality for such software devices. It is becoming increasingly clear that innovation in the AI/ML and digital health technology space is advancing rapidly, as FDA Commissioner Rob Califf has emphasized in many recent public appearances, and that the traditional device framework is quickly becoming unworkable for such technologies.
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New Mexico’s Health Care Consolidation Oversight Act: An Overview
March 11, 2024 | Blog | By Pamela Polevoy, Deborah Daccord
On March 1, 2024, New Mexico joined a growing number of states in enacting legislation that increases oversight of certain health care transactions. Senate Bill 15 (S.B. 15), which adds a new section to the New Mexico Insurance Code (the Code) titled the “Health Care Consolidation Oversight Act” (the Act), takes effect on May 1, 2024.
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FDA Faces Critical Deadlines in 2024, Even Without an Election Looming
March 6, 2024 | Blog | By Joanne Hawana
The American public knows that 2024 is a critical election year, with the next race for the presidency in November expected to be another face-off between President Biden and former President Trump. What the majority may not know quite as well, however, is how many important regulatory programs the Food and Drug Administration (FDA) has tasked itself with completing sometime this year. Given the centrality of much of FDA’s work to the average American consumer and all users of health care services, not to mention the various business stakeholders whose operations can be shaped in part by policy decisions executed by the agency, this blog post will preview upcoming milestones that FDA is expected to meet in 2024.
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California Bill (AB-3129) Targets Private Equity and Hedge Fund Health Care Transactions
March 1, 2024 | Blog | By Kathryn Edgerton, Deborah Daccord, Karen Lovitch
California Attorney General Rob Bonta (AG) and Assembly Speaker pro Tempore Jim Wood recently introduced legislation (AB-3129) that would authorize the AG to review private equity group and hedge fund health care transactions. The proposed legislation’s stated intention is to address price increases and lower quality of and decreased accessibility to services associated with private equity acquisitions of certain health care entities, including physician practices. This article provides an overview of the proposed bill, an analysis of the key issues raised by the proposed legislation, and suggestions for next steps for those potentially affected by the proposal.
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New York City's Health Care Price Transparency Law Takes Effect
February 29, 2024 | Blog | By Jean D. Mancheno, Cody Keetch
In summer of 2023, New York City Mayor Eric Adams signed Intro. 844-A (Local Law 844-A) and amended the New York City Charter. Local Law 844-A directs Mayor Adams to establish an Office of Healthcare Accountability that will serve to increase health care price transparency in New York City. Though health care price transparency laws have been enacted at the state level across the nation, New York City has become the first municipality in the nation to implement a price transparency law. Indeed, New York City Councilmember Julie Menin, who sponsored Local Law 844-A, emphasized “the positive impact of price transparency measures in other states, and it’s time for New York City to curb excessive health care prices” alongside other states during the bill’s signing ceremony. The law took effect on February 18, 2024.
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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 — 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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