Compliance Matters Newsletter | December 2025 - EPIC Insurance Brokers & Consultants

Let our team help you navigate the ever-changing benefits compliance landscape each month. Check out this month’s latest alerts, additional updates, and resources hot off the press:

Employee Benefits Compliance Alerts

This month’s Compliance Matters newsletter provides a comprehensive review of the following topics. To obtain your copy, please use the form below to download.

PCORI Fee Summary & Updated 2026 Fees
Determining ALE Status
TrumpRx Is Coming in 2026
2025 State Regulation Series: New York Age 29 Requirement

Download this month’s alerts

Additional Updates & Resources

Pharmaceutical Recovery Opportunities with EPIC Partner MCAG

In light of the increase in litigation against pharmaceutical manufacturers, EPIC has partnered with Managed Care Advisory Group (MCAG), an experienced class action settlement recovery consulting company, to assist our clients in researching potential opportunities to join class-action lawsuits against pharmaceutical drug manufacturers. These class actions commonly develop as a result of anti-competitive practices undertaken by the drug manufacturers, and the intent is to recover funds for employer health plans that overpaid for drugs purchased on behalf of their employees due to artificially inflated and/or stabilized prices. There are typically several active lawsuits and/or class action settlements that fall into the category of “pharmaceutical benefit plan settlements” being litigated at any given time. While the number of these opportunities in any given year varies, there can be several ongoing at the same time.

MCAG researches potential class action opportunities for employers. Then, they help employers complete necessary paperwork and become a class representative for what will ultimately become a class action settlement. Plan sponsors that act as class representatives can receive more money than from participating in a general settlement, but there is also more work because, in those cases, the plan would be suing the defendants directly. MCAG takes on most of that work for the employer. For more information about available opportunities, reach out to your EPIC representative and schedule a call with MCAG.

Gag Clause Prohibition Attestations Due in December

The Consolidated Appropriations Act of 2021 (CAA) prohibits group health plans and health insurance carriers from entering into agreements with providers, third-party administrators (TPAs), or other service providers that include language that constitutes a “gag clause.” The first attestation was due December 31, 2023, and subsequent attestations are due annually by December 31, making the next submission due December 31, 2025.

While instructions and processes for submitting the gag clause prohibition attestation have not changed from prior years, starting in 2025, plans and issuers must attest that “downstream agreements” are in compliance with gag clause prohibition requirements. A downstream agreement is a contract entered into by a third-party administrator (TPA), pharmacy benefit manager (PBM), or network on behalf of a plan. This new requirement means that even if the plan itself is not a direct party to a restrictive clause, the plan could be noncompliant if its vendors’ subcontracts limit data sharing. Plans are expected to include language in direct contracts requiring vendors not to enter into downstream agreements that would violate the prohibition.

The gag clause prohibition and attestation requirements apply to all group health plans, but not excepted benefits, retiree-only plans, or account-based plans. Both fully insured and self-funded plans are subject to the requirements, as well as grandfathered plans, grandmothered plans, plan subject to the Employee Retirement Income Security Act (ERISA), and non-ERISA plans.

The Centers for Medicare & Medicaid Services (CMS) created a webpage with information about how to comply with the gag clause prohibition, as well as how to attest to compliance. This webpage is the hub for resources and information from CMS on the gag clause prohibition and attestation requirement, and includes a link to the webform for submitting the attestation. For the 2025 attestation period, there are no changes to prior submission requirements or instructions as of the date of publication of this alert.

For questions about the process or to report difficulties with the attestation process, employers or reporting entities should email CMS directly at .

EPIC has created informational resources for our clients’ use. Please reach out to your EPIC account team for more information about how to access these resources. Previous alerts on the gag clause prohibition attestation and a webinar on the attestation requirement and submission process are available below:

Federal Court Vacates §1557 Gender-Identity Rules

In a decision released on October 22, 2025, the United States District Court for the Southern District of Mississippi (the Court), Judge Louis Guiroloa Jr. vacated portions of the May 2024 final rules for Affordable Care Act (ACA) §1557 that prohibit gender identity discrimination. The final rules, released by the Department of Health and Human Services (HHS) under the Biden Administration, relied on Title IX to determine that “discrimination on the basis of sex” specifically includes discrimination based on sexual orientation, gender identity, sex characteristics, pregnancy, and sex stereotypes and therefore is included in the §1557 rules.

The Court ruled that the gender-identity provisions of §1557 exceeded HHS’s statutory authority, citing recent Supreme Court decisions in Bostock v. Clayton County and United States v. Skrmetti. Judge Guiroloa universally vacated the portions of the rule that apply to gender identity. This means the rule applies nationwide, not just to the states that filed the complaint.

Massachusetts HIRD Form Due December 15

Since 2018, Massachusetts has required employers with six or more employees in the state to file a healthcare coverage form called the Health Insurance Responsibility Disclosure (HIRD) that provides information to the state about employer-sponsored health coverage, including information about employee cost, benefits offered, cost-sharing and employee eligibility. The form does not require employers to submit employee-specific information or protected health information (PHI). The state uses the information collected on the HIRD form to assist MassHealth in identifying its members with access to qualifying employer-sponsored coverage through the MassHealth Premium Assistance Program, a program that helps eligible individuals pay for employer-sponsored coverage. The HIRD form will often eliminate the need for employers to complete a separate Premium Assistance Application for the employee.

Information required to submit the form can generally be found in plan documents such as summary plan descriptions (SPDs), summary of benefits and coverage (SBCs) and open enrollment materials. Examples of information required for submission include the employee’s monthly contribution, in-network deductible and in-network out-of-pocket maximum, benefits waiting periods, hours worked per week to qualify for health insurance and other benefits eligibility criteria.

Plan years ending prior to December 31, 2025, should submit the HIRD form using upcoming plan year information for the health plan(s) instead of using the current plan year information. If health plan information such as rates or plan designs is not available before the filing deadline, employers may submit the HIRD form using the current plan year information for the health plan(s).

The 2025 HIRD submission deadline is December 15, 2025, and the form must be filed through the Mass Tax Connect website. Employers with multiple Federal Employer Identification Numbers (FEINs) should file a separate HIRD form for each FEIN. You may access screenshots of the HIRD form and form completion frequently asked questions (FAQs). If you have questions about filing the HIRD, please call the HIRD information line at (617) 466-3940.

IRS HCI Threshold Remains Unchanged in 2026

The Internal Revenue Service announced on November 13, 2025, all cost-of-living adjustments affecting dollar limitations for pension plans and other retirement-related items for tax year 2026 in Notice 2025-67, posted on IRS.gov. Among other limits, the guidance updates that the amount individuals can contribute to their 401(k) plans in 2026 has increased to $24,500, up from $23,500 for 2025. Additionally, the threshold used in the definition of “highly compensated employee” under Internal Revenue Code (IRC) §414(q)(1)(B) remains unchanged from 2025 at $160,000. This is the income threshold used to define highly compensated employees for non-discrimination testing.

Monthly FAQ: How do you determine the Affordable Care Act (ACA) applicable large employer (ALE) status for members of a controlled group?

For purposes of counting full-time equivalents (FTEs), employers/entities that are part of the same controlled group or affiliated service group under Internal Revenue Code (IRS) §414 rules are combined. If together they have 50 or more FTEs, they are considered to be an “aggregated ALE group” subject to §4980H offer of coverage requirements and potential penalties. However, each entity is separately responsible for offering coverage in accordance with §4980H or risks facing potential penalties. The penalty is applied on an individual basis to each entity rather than across the whole controlled group, except that the waiver (for purposes of calculating the penalty under §4980H[a]) is applied on a pro rata basis.