Health Care

Earlier this week, the Biden-Harris Administration, through the Office for Civil Rights (OCR) announced a Final Rule aimed at protecting protected health information (PHI) related to lawfully provided reproductive health care services.  As we discussed last year, the HIPAA Privacy Rule to Support Reproductive Health Care Privacy was proposed in response to concerns about the confidentiality of PHI related to reproductive health care following the decision in Dobbs v. Jackson Women’s Health Organization.  In the executive summary of the Final Rule, OCR emphasized that the changing post-Dobbs legal landscape “increases the likelihood that an individual’s PHI may be disclosed in ways that cause harm to the interests that HIPAA seeks to protect, including the trust of individuals in health care providers and the health care system.”  The Final Rule defines “reproductive health care” as “health care…that affects the health of an individual in all matters relating to the reproductive system and to its functions and processes.” 

On April 23, 2024, the Centers for Medicare & Medicaid Services (CMS) published final rules setting forth Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024--Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program…et al. These sweeping final rules finalized many changes that were introduced in the Proposed 2025 Rules and other changes that were proposed in the Proposed 2024 Rules. The rules will implement changes related to many areas, including, for example, Star Ratings, marketing and communications standards and requirements, agent/broker compensation, health equity, dual eligible special needs plans (D-SNPs), Part D formularies, utilization management, and the Medicare Advantage and Part D application process.

The government’s continued dedication of resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs appears to have borne fruit according to the results of the COVID-19 Fraud Enforcement Task Force’s (CFETF) report released on April 9, 2024. The CFETF, which represents a concerted effort across numerous federal agencies to investigate pandemic-related fraud, has, according to its 2024 report, succeeded in prosecuting over 3,500 defendants in criminal enforcement matters, in bringing civil enforcement actions resulting in more than 400 civil settlements and judgments, and in securing more than $1.4 billion in seizures and forfeitures. The report itself is a showcase of the CFETF’s COVID-19 fraud enforcement efforts to date.

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.

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. 

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. 

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. 

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.

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.

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.

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.

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.

Read about the small biotech exception exempting certain drugs from the  Medicare Drug Price Negotiation Program for the years 2026, 2027, and 2028.

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.