Uncertainty on Health Care Rules Amid Administration Change

In recent months, several changes to healthcare rules regulations focusing on reproductive health care have been introduced. These include (1) privacy protections for reproductive health data under HIPAA, (2) expanding access to OTC contraceptives without cost-sharing, and (3) broader access to certain preventive services without deductibles. Given the likelihood that the new administration may stop or reverse some of these changes focusing on reproductive health care, health plan sponsors should closely monitor potential developments. We will continue to provide updates as the situation evolves.

HIPAA Reproductive Health Care Rule

As we approach the end of the year, health care privacy remains an important topic, especially following recent developments surrounding the HIPAA Privacy Rule. In our previous newsletters, we discussed the final rule issued by the Department of Health and Human Services (“HHS”) in May 2024, aimed at enhancing privacy protections for reproductive health care. This rule, prompted by the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, prohibits the use or disclosure of protected health information (“PHI”) in investigations related to lawful reproductive health care. The deadline for employer sponsored health plans to comply with this regulation is set for December 23, 2024.

However, with the change in the White House, the new administration may seek to roll back the May 2024 privacy protections related to reproductive health care. While the exact actions of the new administration remain uncertain, it is possible that the HIPAA Privacy Rule could be revised or rescinded, creating further ambiguity for employers and health care providers.

Additionally, in September, the Texas Attorney General filed a lawsuit that questions HHS’s authority regarding HIPAA privacy regulations. The Texas AG disputes both the 2000 HIPAA Privacy Rule and the 2024 Reproductive Privacy Rule, drawing on the recent Supreme Court ruling in Loper Bright Enterprises v. Raimondo. It overturned the principle of Chevron deference, which had previously instructed courts to defer to an agency’s reasonable interpretations of laws it oversees. The Texas AG’s lawsuit introduces additional uncertainties about the enforceability of HIPAA, particularly as the new administration determines its approach to the reproductive health care issues and the HIPAA Privacy Rule in general.

It’s crucial for employers who sponsor group health plans to continue to prepare for the December 23, 2024, compliance deadline. You can read our previous newsletter entries on this issue here and here.

Proposed Rules to Expand Preventive Services Coverage and Access to Contraception

In October 2024, the Departments of Health and Human Services, Labor, and the Treasury released proposed rules to enhance coverage of preventive services under the Affordable Care Act (“ACA”). These proposed rules focus on expanding access to preventive services without cost-sharing, with a particular emphasis on improving coverage of contraceptive services, including over-the-counter (“OTC”) contraceptives, such as birth control.

Under the proposed rules, health plans using reasonable medical management techniques for preventive services would be required to implement an accessible, transparent, and expedient exceptions process. This would allow individuals to receive coverage without cost-sharing for preventive services—including contraceptives—that are deemed medically necessary by their provider, even if those services are not typically covered by the plan.

The proposed rules remove previous barriers, such as the prescription requirement, making contraception more accessible. Health plans would be required to cover recommended OTC contraceptives without a prescription and without cost-sharing. Health plans would need to include clear disclosures in their Transparency in Coverage (“TiC”) tools, explaining that OTC contraceptives are covered without a prescription and without cost-sharing. Plans would also need to provide a contact number for further information about contraception coverage.

If finalized, and if not reversed by the new administration, the rules would take effect immediately for the exceptions process and January 1, 2026, for the contraceptive coverage provisions. However, the rules would not affect federal conscience protections, which allow employers and insurers to opt out of providing contraceptive coverage based on religious or moral objections.

Expanded Coverage for Preventive Care Benefits Under HDHPs

In October 2024, the IRS issued two important notices—Notices 2024-71 and 2024-75—that expand the scope of preventive care and medical care benefits under High Deductible Health Plans (“HDHPs”), Health Savings Accounts (“HSAs”), Health Reimbursement Arrangements (“HRAs”), and Health Flexible Spending Accounts (“FSAs”). These updates aim to improve access to critical health services without requiring participants to meet their deductible first.

Notice 2024-71 provides that amounts paid for male condoms are now considered medical care expenses under Section 213(d) of the Internal Revenue Code, making them eligible for reimbursement through tax-advantaged accounts like HSAs, FSAs, and HRAs. This expansion helps ensure that individuals can use their pre-tax dollars for a broader range of preventive care products.

Notice 2024-75 expands the list of preventive care benefits that can be provided by HDHPs without the requirement of meeting the deductible. Specifically, the list now includes OTC oral contraceptives (including emergency contraceptives) and male condoms as eligible preventive care. Additionally, the notice clarifies that breast cancer screenings, continuous glucose monitors for diabetes, and certain insulin products are also considered preventive care and can be covered by HDHPs without impacting the deductible. This aligns with the broader goal of expanding access to essential preventive services, including those related to sexual and reproductive health, diabetes management, and cancer screening.

These changes intend to broaden access to preventive care, while maintaining the tax advantages of HDHPs and pre-tax spending accounts. These updates are effective for plan years beginning on or after December 30, 2022. Employers offering HDHPs, FSAs, HSAs, or HRAs should review their plans and consider updating their benefits and communications to align with the new rules.