News/Blogs

The regulatory landscape for pharmacy benefits is shifting fast – and your clients are going to have questions. A wave of federal legislation and proposed rulemaking from late 2025 into early 2026 is placing new transparency and fiduciary obligations squarely on employer plan sponsors. As their trusted advisor, now is a good time to get ahead of what’s coming. Here’s what you need to know.

Federal Events

There have been many developments affecting pharmacy benefits at the federal level since our last PBM regulation roundup. Here are selected items: 

• The Consolidated Appropriations Act of 2026 (CAA 2026), signed into law on February 3, 2026, adds major PBM transparency and contracting requirements in the commercial market. Among other items, PBMs must provide plan-specific reports to employer plan sponsors and plan fiduciaries, including details on drug utilization, rebates, fees, and other remuneration. For self-funded ERISA plans, PBMs must pass through 100% of drug-related rebates and similar payments and provide annual audit access to rebate records. These requirements become effective for plan years beginning on or after the date that is 30 months after enactment. Plan sponsors also have related obligations under ERISA, including monitoring PBM compliance, reviewing the new disclosures as part of their fiduciary oversight, and furnishing summary information to participants upon request. 
• The DOL released proposed regulations, which, if finalized, would require PBMs to make compensation disclosures to plan fiduciaries in accordance with ERISA’s section 408(b)(2)(B) Compensation Disclosure requirements. The disclosures are intended to make clear to plan fiduciaries (i) the PBM services that will be provided to the plan, and (ii) all compensation expected to be received by the covered service provider (or any affiliate, agent, or subcontractor) in connection with the arrangement. The proposed regulations would also allow plan fiduciaries to audit the disclosures for accuracy. The applicability date applies to plan years beginning on or after July 1, 2026. 
• Under the Affordable Care Act’s Transparency in Coverage (TiC) final rule, non-grandfathered group health plans and issuers must publicly disclose monthly machine-readable files (MRFs) detailing negotiated rates and historical net prices for prescription drugs.  While updated technical specifications for other MRFs (in-network and out-of-network) were finalized with an effective date of February 2026, the Department of the Treasury, the Department of Labor, and the Department of Health and Human Services confirmed that they are separately evaluating RFI comments to inform future rulemaking or to develop specific guidance for the prescription drug file. 
• The Trump Administration launched TrumpRx.gov, a new prescription drug pricing website. The website will not sell medications. Instead, it will help consumers search for drugs and then buy them either directly from pharmacies or websites offered by major manufacturers. 
• President Trump announced “The Great Healthcare Plan,” a broad proposal to lower prescription drug prices, reduce insurance premiums, and expand price transparency.

State Laws and Regulations

At the state level, the focus continues to be on whether ERISA preempts state efforts to regulate PBMs, health plans, and pharmacy networks.  

• The Pharmaceutical Care Management Association (PCMA) sued California in federal court, arguing that ERISA preempts the provision of Senate Bill 41 imposing fiduciary duties on PBMs serving self-insured employer plans. On July 24, 2026, the court dismissed PCMA’s amended complaint for lack of standing but gave PCMA 21 days to amend. The court did not decide the ERISA preemption issue.
• The U.S. Court of Appeals for the Sixth Circuit ruled in favor of McKee Foods Corporation, holding that ERISA preempts the challenged Tennessee pharmacy-network provisions. Those provisions required access for any willing pharmacy and limited the plan’s ability to use cost-sharing incentives to encourage participants to use certain pharmacies.
• New Jersey enacted a law banning copay accumulator programs. The law prohibits insurers and PBMs from using copay accumulator programs that prevent third-party assistance from counting toward a patient’s deductible or out-of-pocket limits. With this action, New Jersey joins a majority of states that have adopted similar restrictions. 

About Serve You Rx®   
Serve You Rx is a full-service pharmacy benefit manager (PBM) with unquestionable flexibility and an unwavering commitment to doing what’s best for its clients. With a fervent focus on those it serves, including insurance brokers, consultants, third-party administrators, and their clients, Serve You Rx delivers exceptional service and tailored, cost-effective benefit solutions. Independent and privately held for nearly 40 years, Serve You Rx can implement new groups in 30 days or less and say “yes” to a wide variety of viable solutions. Known for its adaptability, quality, and client-centricity, Serve You Rx aims to be a benchmark for better client service.