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Elizabeth Nevins

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Elizabeth Nevins is an associate in the Corporate Practice Group in the firm's Dallas office, and a member of the Healthcare team.

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On November 25, 2024, the Illinois State Legislature introduced House Bill 5918 IL HB5918, the Artificial Intelligence Systems Use in Health Insurance Act (“AI Act”). It provides the Illinois Department of Insurance (the “Department”) regulatory oversight of insurers using artificial intelligence for determinations that affect consumers. The proposed bill grants the Department the ability to adopt rules, including emergency rules per the Illinois Administrative Procedure Act, to implement and administer the AI Act.Continue Reading Artificial Intelligence Infiltrating Healthcare in Illinois and its Effects on Insurers

On November 26, 2024, the Centers for Medicare & Medicaid Services (“CMS”) released the contract year 2026 proposed rule for the Medicare Advantage (“MA”) program, Medicare Prescription Drug Benefit Program (“Part D”), Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (the “Proposed Rule”). Likely one of the last significant Medicare reform initiatives of the Biden administration, the Proposed Rule incorporates many of the Administration’s broader policy priorities, focusing on equity, transparency, and modernization in healthcare delivery and oversight.Continue Reading Key Proposals from the CY 2026 Medicare Advantage and Part D Proposed Rule

Over two years into the post-Dobbs era, women’s health is taking center stage in the presidential election. In Dobbs v. Jackson, the Supreme Court overturned protections relating to abortion established in Roe v. Wade. Since then, approximately half of the states across the country have enacted or revived laws that ban or significantly restrict access to abortion. This case and the resulting cascade of legal disputes and legislative battles have created a highly dynamic and precarious legal landscape for women’s health. As a result, providers are left uncertain of their rights and obligations. Women in anti-abortion states face challenges obtaining reproductive care and, if pregnant, other medical treatments unrelated to reproductive care, while hospitals and clinics in nearby states without such restrictions are grappling with overwhelming patient loads. Continue Reading Women’s Health on the Ballot in November: What the Election Could Mean for Reproductive Care and Beyond

In a decision joined by all nine justices, the Supreme Court preserved the Food and Drug Administration’s (“FDA’s”) regulatory approval of mifepristone, ensuring continued access to the widely-used abortion medication across the country. Food and Drug Administration, et al. v. Alliance for Hippocratic Medicine et al., No. 23-235 and Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine, et al., No. 23-236. The Court ultimately decided the case on procedural grounds, holding that the plaintiffs lacked standing to bring suit.Continue Reading Supreme Court Unanimously Preserves Access to Mifepristone

On April 29, 2024, the U.S. Department of Labor (the “DOL”) issued a final rule (the “Final Rule”) rescinding the 2018 Association Health Plan rule (“2018 AHP Rule”), thereby marking a return to the more rigid pre-2018 regulatory framework governing association health plans. The 2018 AHP Rule, officially titled “Definition of Employer Under Section 3(5) of ERISA – Association Health Plans,” allowed these plans to bypass certain requirements under the Affordable Care Act (“ACA”). The Final Rule will take effect on July 1, 2024.Continue Reading U.S. Department of Labor Rescinds Trump-Era Rule on Association Health Plans (AHPs)

On April 4, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued the contract year 2025 (CY2025) Medicare Advantage and Part D final rule (the “Final Rule”). In addition to finalizing its CY2025 proposed rule, CMS also addressed several key provisions that remained from the CY2024 proposed rule. According to CMS’ Fact Sheet, the Final Rule builds on existing Biden-Harris Administration policies to strengthen protections and guardrails, promote healthy competition, and ensure Medicare Advantage and Part D plans best meet the needs of enrollees. The Final Rule also promotes access to behavioral health care providers, promote equity in coverage, and improve supplemental benefits.Continue Reading CMS Issues CY2025 Medicare Advantage and Part D Final Rule

The Department of Health and Human Services (HHS) and the Department of Justice (DOJ) recently released its “Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2022” (the “Report”), highlighting continued enforcement and recovery actions under the Health Care Fraud and Abuse Control Program (HCFAC). During fiscal year 2022 (FY 2022), over $1.7 billion was returned through HCFAC’s enforcement actions.Continue Reading HHS & DOJ FY 2022 Enforcement Targeted Fraud in COVID-19, Telemedicine, Opioid and Prescription Drugs, and Substance Use Treatment Centers, Among Other Initiatives

On November 6, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released the contract year 2025 proposed rule for Medicare Advantage (“MA”) organizations and Part D sponsors (the “Proposed Rule”). The Proposed Rule covers an array of regulatory topics including the Star Ratings program, marketing and communications, agent and broker compensation, health equity, dual eligible special needs plans (“D-SNPs”), utilization management, network adequacy, and access to biosimilars.Continue Reading CMS Promotes Competition, Transparency, Health Equity and More in the CY2025 Medicare Advantage and Part D Proposed Rule

Nearly three months after hearing oral arguments, a divided Fifth Circuit panel issued its decision in Alliance for Hippocratic Medicine v. FDA, upholding the U.S. Food and Drug Administration’s (“FDA”) underlying approval of Mifepristone in 2000, but reinstating the limitations and restrictions under the pre-2016 protocol. Despite rejecting Judge Matthew Kacsmaryk’s blanket suspension of the drug’s approval, the federal appeals court found that the FDA overstepped its authority in expanding access and loosening restrictions on the drug in 2016 and 2021. Specifically, the Fifth Circuit agreed with the lower court’s ruling to invalidate the FDA’s modifications that increased the gestational age and relaxed dispensing requirements such as allowing the drug to be dispensed through the mail and ordered by a non-physician. The 96-page ruling issued by the conservative three-judge panel will likely not have any immediate legal effect, and Mifepristone will remain broadly available due to the Supreme Court’s stay implemented earlier this year.Continue Reading Fifth Circuit Rules to Reinstate Abortion Pill Restrictions

For a brief moment in time last April, the U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. Department of Justice (the “DOJ”) asked the Fifth Circuit to grant an emergency or administrative stay of that decision. On review, the Fifth Circuit held that Mifepristone could only be prescribed in the first seven weeks of pregnancy, under a physician’s supervision, and the drug cannot be sent by mail, temporarily suspending more recent modifications to the FDA’s approval. Continue Reading Access to Abortion Pill on the Precipice: A Deep Dive into the Federal Court Rulings that will Decide the Fate of Mifepristone 

In February, when the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) delivered two annual reports to Congress for the 2021 calendar year as mandated by the HITECH Act, several notable takeaways were exposed. By providing data on enforcement actions and insight into areas of noncompliance, the reports assist HIPAA entities to mitigate risk, prioritize compliance efforts, and promote industry accountability.Continue Reading HHS OCR Delivered Annual Reports to Congress