Health Care

An important new initiative focused on women’s health research – defined as “the study of health across a woman’s lifespan in order to preserve wellness and to prevent, diagnose, and treat disease” – was recently kicked off in the United States. On November 13, 2023 the White House announced the Initiative on Women’s Health Research, to be led by First Lady Jill Biden and the Gender Policy Council. The Initiative aims to recognize and address the historic and persisting gaps in women’s health research and, by extension, in our collective knowledge about women’s health as well as how women experience certain conditions or respond to certain treatments differently than men. 

A year has passed since Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA) and enhanced the Food and Drug Administration’s (FDA) authority to regulate the cosmetics industry. Although MoCRA implementation efforts steadily increased throughout the calendar year, as the December 29, 2023 compliance date for most MoCRA provisions approached, FDA’s release of information and deployment of new systems for the industry came to a climax. Several recent MoCRA-related developments will influence how cosmetic industry stakeholders, consumers, and even the FDA will approach and navigate the law’s requirements over the next year. In this blog post, we will discuss each of these developments and forecast the law’s future as we move into 2024.

California’s new Office of Health Care Affordability (OHCA) is set to start pre-closing regulatory review of certain health care transactions on January 1, 2024. As further explained in our previous post, subject to certain exceptions, a broad range of health care entities (collectively, Health Care Entities) soon will be subject to potential pre-closing transaction review.

In 2023, the FDA navigated challenges while achieving significant public health milestones. Member Joanne Hawana and Of Counsel Benjamin Zegarelli highlight key takeaways from the year, addressing multifaceted issues such as CBD regulation, the overhaul of in vitro clinical tests, and the management of manufacturing failures. These pivotal topics underscore the FDA’s proactive approach to evolving healthcare regulations and technological advancements. 

The U.S. Department of Health and Human Services (HHS) released a concept paper on December 6, 2023 outlining its action plan to enhance cyber resiliency in the health care sector by proposing certain voluntary cybersecurity actions and standards that may ultimately become requirements. For health care organizations such as hospitals, “cyber resiliency” generally means how organizations anticipate, operate during, respond to, and recover from cyber attacks such as ransomware attacks, cloud exploitations, phishing or spear-phishing attacks, software and zero-day vulnerabilities, or distributed denial of service attacks.

Mintz recently launched a new series of Health Law Diagnosed titled Women Leaders in Health Care. This new series highlights women leaders in the health care industry and includes discussions on key issues in the health care industry, women leaders’ reflections on their career, and the impact of mentorship. In our inaugural episode, Leah Pollema, Vice President and General Counsel at InhibRx, and Serene Katranji, Chief Operating Officer, Chief Compliance Officer, and Corporate Counsel at Orchard Laboratories, join host Bridgette Keller to share personal stories about their experiences as both mentees and mentors, shedding light on the invaluable impact mentorship has had on their professional journeys.

This July, we detailed the Supreme Court’s surprising revival in United States ex rel. Polansky v. Exec. Health Resources, No. 21-1052 (S. Ct. June. 16, 2023), of the question of whether the qui tam provisions of the False Claims Act (“FCA”), see 31 U.S.C. § 3730(b)(1), violate the Executive Branch’s exclusive grant of authority under Article II of the United States Constitution. In Polansky, a lengthy dissent by Justice Thomas questioned whether the False Claims Act qui tam provisions violated the Appointments Clause and Take Care Clause of Article II of the United States Constitution, arguments that had been endorsed by the Department of Justice (“DOJ”) in the 1989, though ultimately repudiated by DOJ just seven years later. A concurrence by Justice Kavanagh, joined by Justice Barrett, stated that “the Court should consider the competing arguments on the Article II issue in an appropriate case.” Shortly after Polansky was decided, a defendant in a declined qui tam case pending in the United States District Court for the Northern District of Alabama accepted Justice Kavanagh’s invitation, and moved to dismiss on Article II grounds. In a decision entered in November, the District Court rejected that challenge.

As we wrote about in our prior blog post, on September 29, 2023, John D. Bates of the U.S. District Court for the District of Columbia struck down a federal rule that permitted health plans and pharmacy benefit managers (PBMs) to exclude drug manufacturer copayment (copay) assistance from a patient’s cost sharing limits. In two separate filings this week, HHS signaled that it intends to support the continued use of copay accumulator programs as the industry has been using them since 2021.

California’s new Office of Health Care Affordability (OHCA) is set to begin advance regulatory review of certain health care transactions beginning January 1, 2024. As further explained in our previous post, subject to certain exceptions, a broad range of health care entities (collectively, Health Care Entities) will soon be subject to potential prospective transaction review. OHCA initially published proposed regulations for the new transaction review process in early August (for more details, see our prior post and podcast).  As further discussed in our previous post, these proposed regulations were revised in October and made available on the OHCA website, with a comment period that ended on October 17, 2023. In response to October’s public comments, OHCA has further revised the proposed regulations (Revised Regulations), which are available here. This time however, OHCA has also provided notice of proposed emergency regulatory action, indicating that this version of the regulations will be submitted to the California Office of Administrative Law (OAL) for approval. Once submitted, the public will have five days to provide comments to the OAL. If the OAL approves the regulations, it will file them with the California Secretary of State and the regulations will become effective as emergency regulations for five years as of the filing date. During this period, OHCA will proceed with regular rulemaking action addressing prospective health care transaction review.

On November 13, 2023, Governor Kathy Hochul announced plans to regulate cybersecurity for New York general hospitals regulated under Article 28 of the Public Health Law. As proposed, the regulations will provide an additional level of security for hospitals, which have been increasingly targeted for cybersecurity scams and breaches. The proposed regulations would be additive to those requirements of the federal Health Insurance Portability and Accountability Act (HIPAA), which already includes a variety of requirements meant to safeguard Protected Health Information (PHI). Accompanying the proposed regulations, a $500 million dollar fund has been appropriated under Governor Hochul’s FY24 budget to assist hospitals in complying with the proposed cybersecurity regulations. The funds will be made available through a Health Care Technology Capital program, which will be established by the New York State Department of Health (DOH).

The U.S. Food and Drug Administration (FDA) recently released a proposed rule that would seek to regulate laboratory developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). This rule could reshape the landscape of LDTs and, as expected, has generated substantial attention and feedback from the public, with both supportive and negative comments flooding in. We previously provided a summary of the proposed rule and FDA’s lengthy justification for it here. In this blog post, we will examine some of the key arguments presented in the public comments submitted to Docket FDA-2023-N-2177, as well as public statements published by industry trade associations.

A new battle is emerging in the fight for health equity, and it’s centered on the humble pulse oximeter. On November 1, 2023, 25 state attorneys general sent a letter to the Food and Drug Administration (FDA) demanding that the agency take urgent action to address pulse oximeter inaccuracies that continue to create health care risks for people of color. The letter comes exactly one year after a public meeting held by the Anesthesiology and Respiratory Therapy Devices Panel of the FDA’s Medical Devices Advisory Committee titled “Pulse Oximeter Accuracy and Limitations,” and nearly 21 months after the agency issued a safety communication about pulse oximeter inaccuracies when used on people with dark skin pigmentation (see our previous blog post on pulse oximeter performance here).

Since the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law, cosmetics companies have spent the past year preparing to comply with its provisions. This includes the facility registration and cosmetic product listing requirements that have were mandated by Congress in the new law. Under MoCRA, the statutory deadline for meeting these foundational requirements is set at December 29, 2023 (one year after MoCRA’s enactment). However, on November 8, 2023, the Food and Drug Administration (FDA) issued Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing (Compliance Guidance) and announced that enforcement of facility registration and cosmetic product listing requirements will be delayed six months.

The Department of Health and Human Services’ Office of Inspector General (OIG) published a General Compliance Program Guidance (GCPG) on November 6, 2023, marking the first update to OIG’s compliance program guidance documents (CPGs) since 2008 and advancing OIG’s Modernization Initiative first announced in a September 2021 Request for Information. 

Public Act No. 23-171: An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs (Act) took effect in Connecticut on October 1, 2023. Under the Act, a pharmaceutical manufacturer (PM) that employs pharmaceutical sales representatives (PSRs) is required to register with the Connecticut Department of Consumer Protection (Department) as a so-called “pharmaceutical marketing firm” (PMF). As discussed in our previous blog post, there are few jurisdictions in the United States that require registration or licensure of PSRs, and up until now, these obligations were placed on PSRs at the individual level. However, this new Connecticut law deviates from the typical regulatory scheme. In this post, we will provide an overview of the affirmative obligations that the Act imposes on PMs, PMFs, and PSRs and compare them to the laws, regulations, and ordinances of other United States jurisdictions.

Governor Newsom signed 890 bills and vetoed 156 bills in 2023. Every year, California passes multiple laws that impact health care practitioners and health facilities and, as further described below, 2023 is no exception. From physician assistant supervision to nursing facility informed consent requirements, these laws will present various new compliance considerations for health care practitioners and health facilities as soon as January 1, 2024.

In coordination with the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS) and Office of the National Coordinator for Health Information Technology (ONC) proposed a much-anticipated framework to establish and manage “appropriate disincentives” for health care providers under the Information Blocking Rules. As described in more detail in the blog post, the proposed rule (Appropriate Disincentives Proposed Rule) includes proposed disincentives for (i) hospitals and critical access hospitals (CAHs) participating in the Medicare Promoting Interoperability Program; health care providers eligible for Merit-Based Incentive Payment System (MIPS) adjustments; and health care providers participating in the Medicare Shared Savings Program (MSSP).

On October 30, 2023, the Biden Administration released and signed an Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (Executive Order) that articulates White House priorities and policies related to the use and development of artificial intelligence (AI) across different sectors, including health care.

Perhaps unsurprisingly, the Office of Inspector General for the Department of Health and Human Services (OIG) rejected a manufacturer’s proposal to provide free hearing aids to certain patients if they receive one of the manufacturer’s cochlear implant devices (Proposed Arrangement). In reaching its determination, the OIG reiterated its longstanding concern about free items or services to Medicare and Medicaid beneficiaries because such arrangements could result in steering and unfair competition. Of note, the free hearing aids under the Proposed Arrangement have a retail value of $1,180 to $2,240 which far exceeds the $570 limit imposed under the only potentially relevant safe harbor – the patient engagement and support safe harbor.

U.S. health care attorneys, investors, and industry stakeholders are very familiar with the well-worn mantra that prescription drug and medical device companies are not allowed to “market” or “promote” their otherwise-authorized medical products for unapproved uses, also known as “off-label” uses. Over the past decade or so, this strict rule has been the subject of significant litigation and administrative proceedings seeking to disrupt and ultimately soften the government’s position in this long-standing, complex balancing of competing interests. What has been emerging is a more nuanced modern regime in which a drug or device sponsor’s First Amendment rights to speak responsibly and in a non-promotional way about its own products – as well as health care providers’ interests in gaining access to such information directly from the product sponsor to enhance patient care – are gaining greater recognition than ever before.