Health Care

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.

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. 

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.

Mintz’s annual report on False Claims Act case activity analyzes data from the DOJ and the firm’s Health Care Qui Tam Database, and explores the 2023 spike in FCA case activity, the ongoing moderate decline in health care–related activity, and continuing

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. 

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.

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.

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.

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).

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.

Read about the FTC’s March 5, 2024 workshop on private equity (PE) investments in the health care industry and a joint request for information on the effects of PE transactions in the health care industry issued by the FTC, DOJ, and HHS.

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. 

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.

Read about Sprint for Women’s Health, a first-of-its-kind initiative to commit $100 million for research and development in women’s health, announced by the Advanced Research Projects Agency for Health.

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. 

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.

Read about recent developments related to the IRA’s Medicare Drug Price Negotiation Program, including a judge’s rejection of a Motion for Preliminary Injunction to stop the program and the selected drug manufacturers’ agreements to negotiate with CMS.

Read about how the removal of the average manufacturer price (AMP) cap on Medicaid rebates prompted manufacturers to cut insulin prices to avoid significant payments to Medicaid.

In this edition of the Mintz IRA Update, we cover the status of the negotiations underway between CMS and manufacturers pursuant to the Medicare Drug Price Negotiation Program and current legal challenges to the program, other drug pricing–related IRA initiatives, the IRA’s small biotech exemption, implications associated with removing the average manufacturer price cap on Medicaid rebates, and the Biden administration’s proposed draft guidance on patent “march-in” rights.