PBM Policy And Legislative Update — Fall 2026

FEDERAL LEGISLATIVE ACTIVITY AND OVERSIGHT

Federal Legislative Activity

Although Congress included landmark PBM reform in the 2026 Consolidated Appropriations Act passed on February 3, 2026, legislators continue to introduce bills targeting the PBM industry and PBM related practices. Below is a summary of federal legislative activity from mid-February through June 2026.

INSULIN Act (S. 4189). The INSULIN Act of 2026 would prohibit private-market group health plans and insurers from applying any deductible to selected insulin products and cap the cost of a 30 day supply of insulin at $35 for plan years beginning on or after January 1, 2027; and for plan years beginning on or after January 1, 2028, the cap would drop to the lesser of $35 or 25% of the plan’s or insurer’s net negotiated price. The bill also would require PBMs, third-party administrators, insurers, and other entities providing PBM services to pass through 100% of all rebates, fees, and other remuneration received from drug manufacturers or other third parties that are related to the plan’s insulin utilization. For uninsured patients, the bill would establish a 10-state, 5-year pilot program through which each selected state would receive grant funding to help uninsured individuals access insulin at an “affordable” price. The bill defines “affordable” as an out-of-pocket cost of not more than $35 for a one-month supply.

PBM Kickback Prohibition Act (H.R. 7895). The PBM Kickback Prohibition Act would amend ERISA to prohibit PBMs from directly or indirectly providing referral fees or other compensation to brokers, consultants, advisors, or similar parties for steering employer-sponsored health plan or health insurer business to a particular PBM. However, the bill does not specify penalties (monetary or otherwise) for violations. During an April committee hearing about the PBM business model, the bill’s sponsor, Rep. Rick Allen (R-GA), cited deceptive payment practices between PBMs and brokers and a broader lack of industry transparency as driving reasons for the bill.

Every Dollar Counts Act (H.R. 8270). Recognizing the increased availability and use of direct-to consumer platforms for pharmaceuticals, the Every Dollar Counts Act would require commercial insurers and group health plans to count a patient’s out-of-pocket spending on covered drugs (i.e., those on the plan’s formulary) toward their plan deductible and out-of-pocket maximum, regardless of where the drug is purchased. This approach would align with the one taken by the FTC in its February 2026 settlement with Express Scripts, which requires the PBM to count patient payments through the TrumpRx platform toward the patient’s deductible and out-of-pocket maximums. While proponents of the bill maintain that all patient out of-pocket drug spending should be treated equally, others note that imposing such requirements on insurers’ benefit designs could lead to unintentional consequences, such as increased premiums.

Patients Before Monopolies Act (S. 4509 / H.R. 8779). As we discussed, the reintroduced Patients Before Monopolies Act retains the core prohibition on direct or indirect ownership or control of both a pharmacy and an insurance company or PBM, with a few new enhancements. The updated version accelerates the timeline for compliance (reducing the divestment period to one year), introduces stronger enforcement provisions (including divestment milestones and an escrow requirement for missed milestones), and creates a private right of action with a possible award of treble damages. It also requires the Federal Trade Commission (FTC) and Department of Justice (DOJ) to submit quarterly reports to the relevant congressional committees on compliance with the Act. These changes align the bill more closely with the Break Up Big Medicine Act, which similarly restricts common ownership of certain medical services providers.

Health Data Access, Transparency, and Affordability Act (H.R. 9228). The Health Data Access, Transparency, and Affordability Act would amend ERISA to require that service agreements between group health plans and network service providers (or other entities) give plan fiduciaries the right to access all relevant claims and encounter data, along with supporting documentation such as medical records and policy documents. All required disclosures would remain subject to HIPAA. The bill also specifies a number of prohibited provisions within contracts between group health plans and service providers, including limitations on the amount of claims or encounter data that the plan fiduciary may access. Parties violating the disclosure obligations would be subject to a civil monetary penalty of up to $10,000 per day per violation.

Other Federal Regulatory Activities

CMMI Advances Several Drug Pricing Models. As discussed in our Spring 2026 PBM Update, the Center for Medicare & Medicaid Innovation (CMMI) recently announced several alternative drug pricing models aimed at reducing prescription drug costs.

The public comment period for the mandatory GUARD and GLOBE models closed in late February 2026, with a limited number of public comments released. Both models have since advanced in the regulatory process, with the GUARD and GLOBE final proposed rules submitted to the White House’s Office of Management and Budget (OMB) on June 15 and June 26, 2026, respectively, for final review. The pharmaceutical industry continues to push back on these models, and it’s possible there will be legal challenges.

Meanwhile, progress has been uneven for the voluntary BALANCE model, under which CMS would negotiate prices for GLP-1 medications on behalf of state Medicaid agencies and Medicare Part D plan sponsors. Following limited participation from Part D sponsors, CMS delayed the Medicare component of the model, originally slated for a 2027 launch. The Medicaid component, however, has stayed on track with state participation applications open through July 31, 2026. In response to the delay of the Part D BALANCE model, CMS announced an extension of the Medicare GLP-1 Bridge Program, which will now run through the end of 2027. Through the Bridge Program, which went live on July 1, eligible beneficiaries will have access to select weight-loss drugs (Foundayo, Wegovy (injection and tablets), and Zepbound) with a $50 copay.

CMS also extended participation deadlines for the GENEROUS Model. Manufacturer applications were due July 17, 2026, while states have until September 10, 2026 to apply to participate in the GENEROUS model, subject to any further extensions.

As CMS continues to expand its Innovation Center portfolio, including the alternative drug pricing models, the agency is reportedly seeking to increase staffing to accommodate the needs of these alternative payment models and other CMS initiatives.

CMS Seeks Input on Medicare Part D CAA 2026 Reform Implementation. As we reported, on June 16, 2026, CMS issued a request for information (RFI), Pharmacy Benefit Manager Compensation and Data Collection, seeking stakeholder input on the implementation of Section 6224 of the Consolidated Appropriations Act, 2026 (CAA 2026). Section 6224 imposes new restrictions on PBM compensation in Medicare Part D and establishes reporting requirements that are slated to take effect on January 1, 2028. Through a series of questions focused on defining PBMs, affiliates, bona fide service fees, fair market value, pharmacy payment arrangements, and data collection, CMS signals a strong interest in identifying and monitoring pharmacy benefit compensation arrangements that may fall outside the statutory bounds. The RFI also suggests that CMS intends to prioritize transparency, closely scrutinize remuneration flowing through affiliated entities and indirect pharmacy benefit arrangements, and develop a robust reporting framework to support future oversight and enforcement in the industry.

For additional background on Section 6224 and the broader PBM reforms enacted by the CAA 2026, see our blog post here

DOL Receives Stakeholder Feedback on Proposed PBM Disclosure Rule Following the CAA 2026. As discussed in our Spring 2026 edition of the PBM Update, the Department of Labor (DOL) issued a proposed rule, Improving Transparency into Pharmacy Benefit Manager Fee Disclosure, earlier this year, aiming to clarify how the ERISA provider disclosure requirements under the Consolidated Appropriations Act, 2021 should apply to PBMs. Just days after the DOL announcement, Congress passed the CAA 2026, which included similar PBM disclosure and transparency requirements. This legislation prompted the DOL to extend the comment period for its proposed rule by 15 days to allow stakeholders additional time to comment in light of the new legislation. 

The comment period closed on April 15, 2026, with stakeholders submitting more than 550 comments. As previously discussed, a central theme among commenters concerned the proposed rule’s interaction with the PBM transparency framework of the CAA 2026. Several commenters also questioned the DOL’s authority under ERISA and raised procedural concerns with the rulemaking process pursuant to the Administrative Procedure Act (APA).

OIG: Vertical Integration of Medicare Part D Sponsors and Potential Impact on Drug Costs. On May 19, 2026, amid ongoing concerns about market consolidation and its effect on drug costs and competition, the HHS Office of Inspector General (OIG) posted a report examining the effects of vertical integration and consolidation of Part D sponsors with PBMs and pharmacies, Impacts of Vertical Integration in Medicare Part D on Sponsors’ Drug Costs, Pharmacy Reimbursement, and Enrollee Cost Sharing.

OIG found that although vertically integrated sponsors and nonintegrated sponsors generally achieved similar net drug costs for selected drugs reviewed in the report, these parties generally used different reimbursement strategies in contracting practices. Specifically, OIG noted that while those sponsors that were vertically integrated typically paid pharmacies more upfront, they also recouped more rebates and fees later in the reimbursement process. The report also found that enrollees in plans offered by vertically integrated Part D sponsors generally had lower monthly premium payments, but these enrollees often faced higher out-of-pocket costs when paying for prescription drugs. OIG noted that limitations in available data and ongoing market changes make it difficult to fully assess the impact of vertical integration in the pharmacy benefit space.

FTC PBM Enforcement and Health Care Oversight

The Federal Trade Commission (FTC) reached proposed settlements with the remaining two PBMs, Optum Rx and CVS. In September 2024, the FTC sued three major PBMs (Express Scripts, Optum Rx, and CVS) alleging anticompetitive practices that increased the price of insulin. As we reported, Express Scripts settled earlier this year and agreed to a slew of changes in its drug pricing and rebating process. Recently, it was noted that the FTC reached a settlement in principle with the two remaining PBMs, Optum Rx and CVS. (Notably, in response to a joint stipulation, the Eighth Circuit dismissed the PBMs’ countersuit against the FTC.) Although the details are not yet public, the proposed settlements of Optum Rx and CVS are expected to mirror that of Express Scripts and include large overhauls of the companies’ drug benefit designs. These settlements — and the associated changes — come in the wake of congressional probes concerning the drug rebating process and the role PBMs have in it.

Update Since Publication: The FTC announced its settlement with Caremark Rx, LLC and Zinc Health Services, LLC on July 14, 2026, which is the second of the insulin pricing settlements to be made public. The settlement closely tracks the previously announced settlement with Express Scripts, with some notable differences. See our discussion for more information.

FTC Launches Healthcare Task Force. As we previously reported, the FTC announced the launch of a Healthcare Task Force on March 20, 2026, signaling a significant escalation in the FTC’s approach to health care oversight. The multi-bureau group, comprised of members of the Bureaus of Competition, Consumer Protection, and Economics, as well as the Office of Policy Planning and the Office of Technology and possibly others from law enforcement and health departments, “will devise coherent agencywide strategies on new and nascent investigations, institute a proactive and strategic approach to identifying amicus and statement of interest opportunities and conduct ongoing horizon-scanning exercises to identify emerging issues and new priority areas for enforcement and advocacy,” according to FTC Chairman Andrew Ferguson. The launch indicates a transition away from ad hoc health care enforcement toward an institutionalized and coordinated approach. The Task Force is directed to partner with the Department of Health and Human Services (HHS) and DOJ to capitalize on subject-matter expertise, access to data, regulatory insights, and enforcement options that do not reside within the FTC itself. Direct Task Force action remains to be seen, but industry observers agree that the FTC is positioning itself as a central enforcement player in health care regulation.

Updates on Trump Administration Initiatives

Most Favored Nations Deals

As previously reported, despite bipartisan hesitation in Congress, the White House continued efforts to codify President Trump’s MFN drug pricing deals. According to reports from March 2026, in an effort to gain industry support for federal legislative efforts to codify the deals, the administration drafted legislative text and invited a small group of pharmaceutical manufacturers to discuss the proposals. However, members of Congress demanded answers and detailed information about the terms of the MFN agreements before considering legislation to codify the deals. For example:

• On March 5, 2026, Rep. Daniel Meuser (R-PA) introduced the Most Favored Patient Act of 2026 (H.R. 7837), which would require CMS to test a model implementing MFN pricing starting in 2029.
• On April 21, 2026, Sen. Ron Wyden (D-OR) and 18 co-sponsoring senators introduced the Drug Deal Disclosure Act (S. 4355), which would require HHS to disclose documents and information related to any agreements entered into by the Trump administration and any drug manufacturer related to: MFN pricing (including the specific agreements the administration announced and any future agreements), direct-to-consumer sales or discounts, import duty exclusions or exemptions, investments in or repatriation of revenue to the United States, special treatment under CMS demonstration projects, contributions to or agreements regarding the Strategic National Stockpile, or receipt of a Commissioner’s National Priority Review Voucher through the FDA’s pilot program.

On April 23, 2026, Regeneron, the last of the 17 manufacturers that originally received letters from the Trump administration, announced an MFN pricing deal. As with the deals we covered in our Spring 2026 PBM Update, Regeneron agreed to provide select products, including its cholesterol medicine Praluent, at a discounted rate through TrumpRx, and has pledged more than $9 billion in US manufacturing and research and development investments. Regeneron also agreed to provide its brand-new gene therapy, Otarmeni (used to treat a rare genetic deafness), at no cost to patients in the United States. As with the other 16 MFN pricing deals, the Trump administration will exempt Regeneron from future pricing mandates and provide tariff relief for three years in exchange for reaching an MFN pricing and onshoring agreement.

With the MFN deals now in place, attention has turned to whether the agreements will deliver meaningful cost savings.

• In May 2026, the Council of Economic Advisers for the Trump administration published a report, “Savings from Most Favored-Nation (MFN) Drug Pricing Policy,” in which the Council notes that it projects to see $529 billion in MFN pricing-related savings over the next decade, which will result from “tying US drug prices to international prices, [which] will lower US prices and put pressure on prices paid in other wealthy nations.”
• In the same month, AARP published a report examining the price trajectory of the top 25 brand-name drugs, finding that the price of these drugs rose by an average of 81% in the US, while prices for the same drugs fell an average of 13% across other comparable countries.
• In addition, PhRMA recently published a report highlighting that high US drug spend is about more than just the price of drugs — it is also due to the availability and coverage of new medications, with 88% of new medicines covered by US public insurance compared to 36% abroad; and compared to patients in foreign nations, US patients wait a fraction of the time to access new medications.

These competing analyses underscore the uncertainty surrounding MFN pricing’s real-world impact, leaving stakeholders to watch how savings projections hold up against entrenched market dynamics.

Tariffs

Citing the International Emergency Economic Powers Act, the Trump administration has used tariff threats and tariffs themselves to negotiate trade deals with foreign nations. However, on February 20, 2026, the Supreme Court ruled that the International Emergency Economic Powers Act does not allow President Trump to unilaterally impose tariffs. Many foreign nations now question the status of their trade deals. The ruling also calls into question the impact on tariffs related to pharmaceutical drugs, which were originally levied under Section 232 of the Trade Expansion Act and which led manufacturers to pledge billions of dollars toward US-based research and development in exchange for tariff relief. In response to the Supreme Court’s ruling, President Trump signed an order imposing a 10% global tariff under Section 122 of the Trade Act of 1974, which allows for the imposition of this tariff for 150 days, provided the global tariff excludes pharmaceuticals and pharmaceutical ingredients.

As we reported, to separately target pharmaceuticals, President Trump announced a new 100% tariff on patented pharmaceutical products and ingredients under Section 232.

TrumpRx

Since launching TrumpRx, the Trump administration has made efforts to expand the platform offerings by adding over 700 drugs to the original list of 43 branded prescription drugs.

• To date, many manufacturers that previously reached MFN deals with the administration now sell medications through the TrumpRx website. In addition to AstraZeneca, Eli Lilly, EMD Serono, Novo Nordisk, and Pfizer, other manufacturers, including Johnson & Johnson, Amgen, GSK, Boehringer Ingelheim, Abbvie, and Genentech have since started selling some of their most popular medications through TrumpRx (e.g., Abbvie’s Humira).
• To further expand the reach of the TrumpRx platform, on May 18, 2026 President Trump announced that TrumpRx would be adding over 600 generic drugs, with a second expansion announcement on June 6, 2026 making another 160 prescription drugs available through TrumpRx.
• Expansion efforts also include partnerships and integration efforts with Mark Cuban and the Cost Plus Drugs platform, as well as drug savings and low-cost prescription programs offered through GoodRx and Amazon Pharmacy.

Echoing the uncertainty surrounding MFN pricing’s projected savings, critics have questioned whether TrumpRx fulfills the administration’s promise of offering “the world’s lowest prices on prescription drugs.” Comparative analyses suggest the claim falls short in many cases — Novo Nordisk’s Wegovy, for instance, costs less through TrumpRx than in Canada but more than what patients pay in Germany, Britain, or Japan, and reports indicate that about one-third of TrumpRx drugs would be cheaper in the United Kingdom. Additional concerns include the program’s prohibition on insurance use or applying purchases toward deductibles, the reality that many patients’ existing copays are lower than TrumpRx prices, and the impact on pharmacies that must absorb the difference between wholesale costs and reduced reimbursement rates.

Update Since Publication: On August 13, 2026, PCMA and 10 PBMs — CarelonRx, CVS Health, Express Scripts, Humana, MedImpact Healthcare Systems, Navitus Health Solutions, Optum Rx, Prime Therapeutics, VytlOne, and WellDyne — announced an agreement to list their negotiated plan prices alongside the cash prices on TrumpRx, allowing enrolled patients to compare PBM benefit pricing with direct-to-consumer prices available through the platform.

Notably, the administration exempts from tariffs, through January 20, 2029, companies that have entered into both an MFN pricing agreement with the HHS and an onshoring agreement with the Department of Commerce. The Presidential Proclamation related to the new tariff also includes total or partial exemptions for countries with trade deals, generic pharmaceuticals, and certain specialty pharmaceutical products.

Following President Trump’s direction to impose 100% tariffs on pharmaceutical companies that did not previously enter into MFN and onshoring agreements, the Department of Commerce released guidance for how other pharmaceutical companies can apply to enter into onshoring agreements that would reduce the tariff to 20%, with the possibility of being further reduced to 0% if such company enters into an MFN deal with HHS. The application requires companies to provide current and prospective (i.e., January 20, 2025 through January 20, 2029) responses describing the companies’ plans for, among other things, (1) new US-based investments including manufacturing plants, (2) onshoring of global production of pharmaceuticals and pharmaceutical ingredients, (3) percentage of US sales consisting of patented pharmaceuticals with active ingredients, and (4) products that will not be manufactured in the US with an explanation for why it is not commercially feasible to do.

As a response to the Trump administration’s tariff practices, on May 22, 2026, Sen. Gary Peters (D-MI) and Sen. Susan Collins (R-ME) introduced a bipartisan bill aimed at increasing transparency requirements related to tariff investigations conducted by the Department of Commerce under the Trade Expansion Act. The bill seeks to amend the Section 232 Public Transparency Act by requiring the Secretary of Commerce to “publish summaries of its investigations examining alleged national security risks tied to imports of certain goods,” which the Trump administration has used as its explanation for levying tariffs on the importation of pharmaceuticals, among other things.

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