On June 13, 2024, the U.S. Supreme Court ruled in FDA v. Alliance for Hippocratic Medicine that a group of doctors challenging the FDA’s approval of the abortion medication mifepristone lacked legal standing, thus preserving access to the widely used abortion pill. Mifepristone is used in about two-thirds of U.S. abortions. This decision does not preclude other challenges to mifepristone’s legality. Therefore it is possible that the Court could still rule against continued access to the medication in a later court decision.

On May 13, 2024, the 11^th Circuit Court of Appeals affirmed in Lange v. Houston County a lower court’s decision holding that a self-insured health plan’s exclusion of gender-affirming healthcare violated Title VII of the Civil Rights Act of 1964. The lawsuit was brought by a transgender employee whose physician recommended gender-affirming surgery and hormone therapy to treat gender dysphoria. The employee’s healthcare provider determined that her gender-affirming healthcare was medically necessary. However, her request for coverage was denied based on the health plan’s exclusion of gender-affirming care. The district court granted summary judgement confirming the health plan’s exclusion was discriminatory under Title VII and the 11^th Circuit affirmed the district court’s ruling.

On April 30, 2024, the U.S. Department of Labor issued a final regulation (“Final Rule”) formally rescinding its 2018 Association Health Plan (AHP) rule (“Former Rule”) making it more difficult to form an AHP. The 2018 Former Rule was previously invalidated through a series of lawsuits brought by 11 states and the District of Columbia. These suits claimed that the standards in the Former Rule strayed too far from the statutory definition of an employer under ERISA. As background, AHPs allow multiple unaffiliated employers without common control or ownership to form an association to provide health coverage and thereby receive the cost benefits of a large single employer group health plan. The Final Rule removes the Former Rule’s alternative criteria to define an employer in AHPs and replaces it with the more rigid pre-2018 criteria. The Final Rule will go into effect on July 1, 2024.

As the month of May begins, it is important to remember that the Prescription Drug Data Collection (RxDC) Reporting deadline is just a month away – June 1^st. Required under the Consolidated Appropriation Act, 2021 (CAA), this annual reporting of certain prescription drug and healthcare spending from the prior year aims to improve transparency. For additional information, see our prior eAlert that discusses updates to this year’s reporting requirements.

On April 23, 2024, the Department of Health and Human Services (HHS) released an Update on their progress with the Advanced Explanation of Benefits (AEOB) requirement under the Consolidated Appropriation Act, 2021 (CAA). Part of the CAA’s goal to ensure greater transparency, the CAA requires health plans to produce an AEOB and distribute it to plan enrollees and beneficiaries. The AEOB must include a Good Faith Estimate (GFE) of the cost to the enrollee as well as what the plan is expected to pay and network status. The AEOB and GFE requirement is still under review and will not be enforced until the proper infrastructure and technology are in place for transmitting the requisite data.

On April 19, 2024, the Department of Health and Human Services (HHS) issued FAQ guidance (“Guidance”) providing clarifications and updates regarding their investigation of the Change Healthcare cybersecurity incident. In February 2024, Change Healthcare, a subsidiary of UnitedHealth Group (“United”), was hacked by a group of cyber criminals who breached patient records, stealing large amounts of HIPAA protected health information (PHI). The cyber criminals involved claim to have stolen millions of medical records, impacting United’s commercial and Medicare/Medicaid plans. HHS is working to repair service and ensure that billing for the Medicare and Medicaid accounts handled by Change Healthcare can continue to bill, in addition to re-securing the breached PHI.

The deadline for filing 2023 annual reporting form (ARF) for the San Francisco Health Care Security Ordinance (HCSO) is just around the corner – May 3, 2024. The ARF requires, among other items, that employers subject to this ordinance report on total healthcare expenditures paid on employees’ behalf for each quarter of 2023.

As background, employers with at least one employee within the city of San Francisco who works more than 8 hours per week for more than 90 days are subject to the HCSO and are required to spend a certain amount on healthcare for their covered employees (called an “expenditure”). These funds can be used toward employer-sponsored medical, dental or vision insurance, paid to the city or contributed toward programs that reduce employee out-of-pocket healthcare costs.