The Federal Trade Commission has reached a proposed settlement with CVS Caremark over allegations that the pharmacy benefit manager artificially inflated insulin prices and impeded patient access to the medication, according to a document filed on the agency’s website in late March 2026.

The proposed agreement follows a pattern established weeks earlier when Cigna’s Express Scripts reached a final settlement with the agency over substantially similar allegations. Both cases originate from a complaint the FTC filed in September 2024 against three of the largest pharmacy benefit managers (PBMs) operating in the United States: CVS Caremark, Express Scripts, and UnitedHealth’s OptumRx. The third named defendant, OptumRx, has not yet reached a resolution with the agency.

CVS acknowledged the proposed settlement in a written statement, noting that the agreement remains subject to review and approval by the FTC chair and that final terms are still pending. The company indicated it expected the settlement process to conclude within weeks of the announcement.

The proposed resolution carries considerable implications for the broader debate over pharmaceutical pricing structures in the United States, and for the millions of patients with diabetes who depend on insulin as a life-sustaining therapy.

The Role of Pharmacy Benefit Managers in Drug Pricing

To understand the nature of the allegations, a working knowledge of PBM operations is necessary. Pharmacy benefit managers function as intermediaries between drug manufacturers, insurance plans, and the retail pharmacies that dispense medications to patients. In theory, PBMs negotiate rebates and discounts from manufacturers on behalf of plan sponsors, passing savings to patients and payers. In practice, critics have argued for years that the rebate system creates perverse financial incentives that favor high-list-price drugs over lower-cost alternatives.

Insulin provides the most clinically consequential illustration of this dynamic. Multiple biosimilar and lower-cost insulin formulations have become available in the United States in recent years, yet formulary decisions made by PBMs have in some cases directed patients toward higher-priced brand products. The FTC’s complaint alleged that CVS Caremark, along with Express Scripts and OptumRx, structured their formularies and rebate negotiations in ways that artificially elevated the prices patients paid and restricted access to more affordable options.

The three companies named in the September 2024 complaint collectively manage pharmacy benefits for the majority of insured Americans, a concentration of market power that the FTC identified as central to its concerns. When entities controlling such a substantial share of formulary decisions favor high-rebate, high-list-price products, the downstream effect on patient out-of-pocket costs can be considerable.

Clinical Stakes for Patients with Diabetes

The clinical urgency underlying these allegations warrants direct attention. Insulin is not an elective or supplementary therapy for patients with type 1 diabetes mellitus (T1DM) and for many patients with type 2 diabetes mellitus (T2DM). Insulin deficiency, or the inability to obtain adequate insulin due to cost barriers, results in hyperglycemia, diabetic ketoacidosis (DKA), and, in severe cases, death. The condition is not manageable through lifestyle modification alone for patients requiring insulin therapy.

Research published in peer-reviewed literature over the preceding several years has documented insulin rationing as a measurable clinical phenomenon in the United States. Patients reporting cost-related underuse of insulin demonstrate higher rates of emergency department utilization, hospitalization for DKA, and diabetes-related complications compared with patients who maintain consistent access. The harm attributable to cost barriers is therefore not theoretical but has been documented across clinical settings.

Hawaii’s patient population carries a particular burden in this context. The state reports elevated rates of T2DM among Native Hawaiian and Pacific Islander communities, populations that face both higher disease prevalence and documented disparities in access to consistent pharmaceutical care. For these patients, formulary structures that effectively elevate insulin costs translate into direct health consequences.

The FTC’s Enforcement Posture

The FTC’s September 2024 complaint represented an unusually assertive use of federal regulatory authority directed at the PBM sector. The agency had spent several years investigating PBM practices, releasing an interim staff report in 2022 and a more comprehensive analysis in subsequent years, before proceeding to formal litigation.

The complaint against CVS Caremark, Express Scripts, and OptumRx alleged conduct that the agency characterized as anticompetitive and harmful to patients. The specific allegations centered on the manipulation of insulin pricing through rebate arrangements that created financial incentives for PBMs to prefer high-list-price formulations and on formulary designs that effectively blocked or disadvantaged lower-cost insulin alternatives.

Express Scripts reached its final settlement with the FTC in February 2026, establishing a precedent against which the CVS Caremark proposed agreement is now being evaluated. The structure and terms of the Express Scripts settlement have not been fully disclosed in publicly available documents, though the conclusion of that agreement accelerated expectations that CVS Caremark would follow a similar path.

The CVS settlement, once finalized, will leave OptumRx as the sole remaining defendant from the original September 2024 complaint without a resolution. The FTC’s success in securing agreements from two of the three named defendants may increase pressure on OptumRx to negotiate, though the agency’s posture toward that case has not been publicly characterized in the available record.

Regulatory and Structural Context

The FTC’s enforcement action against these three PBMs does not exist in isolation. Congressional attention to PBM practices has intensified considerably over recent years, with multiple legislative proposals directed at increasing PBM transparency, restricting spread pricing, and mandating pass-through of manufacturer rebates to patients at the point of sale. None of these proposals has yet been enacted into federal law in comprehensive form, leaving regulatory enforcement as the primary mechanism for addressing the conduct the FTC has identified.

The Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) have separately examined PBM practices within the Medicare Part D program, and rulemaking activity at CMS has sought to modify rebate structures in ways that reduce beneficiary cost exposure. The interaction between these administrative efforts and the FTC’s litigation-based enforcement represents a multi-front regulatory pressure on PBM business models that has no recent precedent in scope.

For CVS Caremark specifically, the proposed settlement arrives during a period of substantial organizational and financial pressure on the broader CVS Health enterprise. The company has faced challenges across its pharmacy retail, insurance, and PBM segments, and the resolution of federal litigation over insulin pricing removes one source of regulatory uncertainty even as final terms remain to be confirmed.

What Settlement Means for Patients

The practical consequences for patients depend heavily on the specific terms of the finalized agreement, which CVS indicated would not be disclosed until the settlement receives FTC chair approval. Settlements in FTC enforcement matters of this type typically include injunctive provisions requiring changes to business practices, though monetary relief structures vary and the extent to which any settlement terms directly reduce patient cost exposure is not determinable from the available record.

The precedent established through the Express Scripts resolution and the anticipated CVS Caremark agreement does, however, signal that the FTC regards PBM conduct in the insulin market as within the scope of its enforcement authority and is willing to pursue formal resolution through litigation and negotiated agreements. Whether this enforcement activity produces durable changes to formulary practices across the PBM sector will depend on the scope of behavioral remedies included in the final terms, and on whether OptumRx reaches a comparable resolution.

Clinicians treating patients with diabetes, particularly in primary care and endocrinology practices, have for years navigated formulary barriers that complicated insulin prescribing. A regulatory environment that constrains PBM manipulation of insulin formularies could reduce administrative burden for prescribers and, more consequentially, reduce the frequency with which patients face cost barriers to obtaining prescribed therapies.

The Hawaii diabetes care community, including the Hawaii Medical Association’s clinical working groups on endocrine disease and health equity, has consistently identified pharmaceutical access as a structural determinant of outcomes for patients with T1DM and insulin-dependent T2DM. Federal enforcement actions that address systemic pricing manipulation represent a development of clinical relevance to practitioners across the state, even as the full terms of any resolution await confirmation.

The proposed CVS Caremark settlement is expected to be finalized within weeks, at which point the specific terms of the agreement will become available for analysis. Until that disclosure, the scope and durability of patient benefit from the FTC’s enforcement effort remain subjects of informed anticipation rather than confirmed outcome.