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PBM Policy and Legislative Update — Winter 2024

April 9, 2024 | Blog | By Theresa Carnegie, Tara E. Dwyer, Rachel A. Alexander, Bridgette Keller, Madison Castle, David Gilboa, Xavier Hardy, Abdie Santiago, Hassan Shaikh, Sophia Temis

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As promised in the U.S. Department of Health and Human Services (HHS) concept paper in December 2023, the agency published voluntary health care and public health cybersecurity performance goals (HPH CPGs) in January 2024 and then proposed in the HHS FY 2025 Budget to establish certain HPH CPG compliance incentives and penalties for hospitals.
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In vitro diagnostics, or IVDs, have a somewhat unique position among the gamut of products that the Food and Drug Administration (FDA) oversees and regulates on behalf of the U.S. public. IVDs are classified as medical devices and include “reagents, instruments, and systems intended for use in diagnosis, including determining the state of health, through the collection, preparation, and examination of specimens taken from the human body.” Unlike human drug and non-IVD device products, which generally must be authorized for a specific medical use prior to commercialization, IVD products may be sold for certain scientific research studies without FDA authorization, but such IVD products may not be sold for clinical diagnostic use.
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New Biden Executive Order Emphasizes Women’s Health

March 27, 2024 | Alert | By Pamela Mejia, Anthony DeMaio

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A Mintz Health Care Roundtable: Current Trends in State Health Care Transaction Review and What to Expect in 2024

March 27, 2024 | Blog | By Stephnie John, Daniel Cody, Deborah Daccord, Karen Lovitch

States are increasingly exercising regulatory oversight of health care transactions by enacting laws requiring prior notice or approval of certain health care transactions. Currently, 15 states have enacted health care transaction review laws applicable to for-profit transactions. On Wednesday, March 20, 2024, Mintz members Daniel A. Cody, Deborah A. Daccord, and Karen S. Lovitch engaged in an insightful discussion with Lois Johnson, General Counsel of Massachusetts Health Policy Commission, to discuss the latest developments surrounding these laws and gain valuable insight from Ms. Johnson’s expertise, as Massachusetts was one of the first states to implement a health care transaction review process. The highlights of this informative conversation are summarized below, and the webinar can be viewed here.
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In the latest episode of Health Law Diagnosed – Women Leaders in Health Care, host Bridgette Keller is joined by women leaders in health care to discuss the emerging role of artificial intelligence (AI) in health care. This is the second episode of Mintz’s Women Leaders in Health Care – a series that highlights women leaders in the health care industry. In this episode, Jane Moran, Chief Information and Digital Officer at Mass General Brigham; Rebecca Mishuris, Chief Medical Information Officer and Vice President at Mass General Brigham; and Carina Edwards, Chief Executive Officer at Kipu Health discuss opportunities for enhanced patient-provider interactions and improvements in health care delivery through the use of AI.

Get to know Jane, Rebecca, and Carina as they answer questions on their career, their advice for women in the health care industry, and the meaning of success and mindfulness.
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In the latest episode of Health Law Diagnosed – Women Leaders in Health Care, host Bridgette Keller leads a conversation around the emerging role of artificial intelligence (AI) in health care.
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Indiana Joins States Focusing on Consolidation of Health Care

March 19, 2024 | Blog | By Pamela Polevoy, Deborah Daccord

On March 13, 2024, Indiana joined the ranks of states exercising greater oversight and regulation of health care transactions. Senate Enrolled Act No. 9 (S.B. 9), which takes effect on July 1, 2024, requires written notice to the Indiana Attorney General (the AG) 90 days in advance of an acquisition or merger involving an Indiana “health care entity” that results in a change of control. The law does not grant the AG authority to approve or deny a transaction, but the AG may evaluate any antitrust concerns and issue a civil investigative demand for additional information.
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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.
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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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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).
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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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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

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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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ARPA-H Commits $100 Million to Accelerate Women’s Health Research through Sprint for Women’s Health

February 28, 2024 | Alert | By Pamela Mejia, Sarah C. Palmer, Anthony DeMaio

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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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