Health Law Advisor

Oregon’s HB 4088A, introduced in the state legislature during the 2024 session, died in the Joint Ways and Means Committee when the legislature adjourned on March 7. The legislation was intended to strengthen Oregon’s workplace violence prevention laws by adding regulatory requirements and enhancing the criminal repercussions for assault of hospital workers. While most of the bill had bipartisan support, section 6 of the proposed legislation, which would have made the assault of a hospital worker a felony instead of a misdemeanor, garnered strong opposition.

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Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others—to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug Pricing Program (the “340B Program” or the “Program”). Specifically, industry stakeholders have until April 1^st to submit comments to legislators regarding the Discussion Draft Explanatory Statement and Supplemental RFI (the “RFI”) of the “Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now ...

On March 13, 2024, Indiana Governor Eric J. Holcomb signed Senate Enrolled Act No. 9 (“SEA 9”) which will amend the Indiana Code with respect to notice of health care entity mergers and acquisitions.

The measure, effective July 1, 2024, adds a new Chapter 8.5 to the Indiana Code providing in Section 4(a) that “[a]n Indiana health care entity that is involved in a merger or acquisition with another health care entity with total assets, including combined entities and holdings, of at least ten million dollars ($10,000,000) shall, at least ninety (90) days prior to the merger or ...

On February 28, 2024, bipartisan legislation was introduced in the Connecticut General Assembly by the State Senate and House of Representatives that would require the executive director of the Office of Health Strategy to develop a plan concerning private equity firms acquiring or holding an ownership interest in health care facilities in the state.

Raised HB 5319, sponsored by Sen. Jeff Gordon (R) and Sen. Saud Anwar (D), was referred to the state’s Joint Committee on Public Health. A public hearing was held on March 6.

This legislation, and related bills around the country, are ...

On March 18, 2024, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued updated guidance regarding the use of online tracking technologies by entities and business associates subject to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).

Notably, the updated guidance replaces OCR’s original guidance issued in December 2022, both of which warn companies subject to HIPAA, Covered Entities and their Business Associates (collectively “Regulated Entities”), that use of online tracking technologies, such ...

On March 5, 2024, the Food and Drug Administration (FDA) issued its “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry” (“Final Guidance”). The purpose of the Final Guidance is to assist manufacturers and distributors of new dietary ingredients (“NDIs”) and dietary supplements in preparing and submitting new dietary ingredient notifications (“NDINs”) to the FDA.

The Final Guidance finalizes Section V, “NDI Notification Procedures and Timeframes,” of a 2016 revised Draft Guidance (“Draft ...

Healthcare organizations continue to be prime targets of cyberattacks. It is well-established that cyberattacks can lead to financial loss, reputational damage, and, in some cases, risks to patient care and safety. The recent and well-publicized cybersecurity incident affecting Change Healthcare further evidences these risks. As a result of the widespread and disruptive impact of this most recent cyberattack on the healthcare ecosystem, on March 5, 2024 the U.S. Department of Human Services (HHS) issued a public statement and has also announced that it opened an ...

On February 22, 2024, legislation was introduced in Minnesota’s House of Representatives that would prohibit private equity companies or real estate investment trusts (REITs) from acquiring or increasing any direct or indirect ownership interest those entities have in a health care provider after August 1, 2024.

H.F. No. 4206, authored by state Rep. Jessica Hanson and referred to the Commerce, Finance, and Policy Committee, would also prohibit private equity or REITs from acquiring or increasing any operational or financial control those entities have over a provider, after ...

As our December 2023 Insight noted, California’s SB 184 (enacted in June 2022) and accompanying regulations contain pre-transaction notice requirements by “specified health care entities” for certain “material change transactions” involving the provision of “health care services” in the state. SB 184, which takes effect on April 1, 2024, also established a state Office of Health Care Accountability.

While many transactions involving health care entities will already face the notice requirements of SB 184, AB 3129, introduced by California Assembly Member ...

In response to the recent turmoil caused by the Alabama Supreme Court’s February 16th ruling in LePage et al., v. The Center for Reproductive Medicine et al. and Burdick-Aysenne et al., v. The Center for Reproductive Medicine et al.  that pre-embryos are human children for the purposes of advancing a wrongful death claim, the Alabama legislature enacted a law intended to shield those who “provide or receive goods or services related to in vitro fertilization [(“IVF”)]” from any “action, suit, or criminal prosecution for the damage to or death of an embryo[.]” AL SB ...