Comments to the FTC supporting and offering recommendations on proposed order and settlement with Caremark Rx L.L.C. and Zinc Health Services L.L.C.
Office of the Secretary
600 Pennsylvania Avenue, NW
Washington, DC 20580
To the Commission:
The HIV+Hepatitis Policy Institute is a national organization promoting quality and affordable healthcare for people living with or at risk of HIV, hepatitis, and other serious and chronic health conditions. We write to express our support for the proposed settlement with Caremark Rx, L.L.C. and Zinc Health Services, LLC (collectively “Caremark”), to highlight several provisions that will significantly improve affordability and access to medications for patients, and to propose critical enhancements to further strengthen the order’s protections.
For individuals managing chronic conditions like HIV and hepatitis, the cost of prescription medications is often the single most important factor in treatment adherence and long-term health outcomes. Access to and affordability of those medications are mainly controlled by Pharmacy Benefit Managers (PBMs), such as Caremark. We commend the Commission for reaching a second settlement in this matter and particularly applaud the following provisions of the proposed order:
Aligning Patient Cost-Sharing with Net Drug Prices (Section 2)
For too long, PBMs and insurers have profited at patients’ expense by charging them more at the pharmacy counter than the plan’s actual net cost for a drug, particularly through deductible and coinsurance designs. For people living with chronic conditions who rely on lifelong therapy, including many people living with HIV, coinsurance tied to list prices can lead to large and unpredictable pharmacy bills. These costs often occur early in the plan year when deductibles reset, creating financial barriers that can force patients to delay or abandon medications and undermine adherence.
By requiring Caremark’s standard offering and Aetna’s fully insured health plans to limit patient cost-sharing to the drug’s net cost and prohibiting cost-sharing tied to list price or any higher benchmark, this order ensures that the savings negotiated with manufacturers are finally shared with patients at the pharmacy counter.
Counting TrumpRx Patient Payments (Section 3)
Last November, the HIV+Hep joined 19 other patient advocacy organizations in sending a letter to HHS Secretary Kennedy urging the administration to work with insurers and PBMs to ensure that payments made through the TrumpRx platform count toward patients’ cost-sharing obligations.[1]
While direct-to-consumer platforms offering lower-priced medications may benefit some patients, their impact can be limited if purchases made through these platforms are not integrated into existing insurance protections. Without such integration, patients could pay significant amounts for necessary medications without those payments helping them meet their deductible or annual out-of-pocket maximum.
We support the provision requiring Caremark’s standard offering to ensure that patient payments made through the TrumpRx platform are attributed toward deductibles and out-of-pocket maximums. We note that this provision is contingent on legislative or regulatory changes to exempt direct-to-consumer purchases from the calculation of rebates under the Medicaid Drug Rebate Program and Section 340B of the Public Health Service Act. We urge the Commission to coordinate with CMS and HRSA to pursue regulatory solutions that would activate the TrumpRx provisions in these settlements, rather than waiting for Congress to act. We further urge the Commission to apply this protection across all Caremark-administered plans to ensure consistent patient safeguards, as further detailed in our recommendations below.
Allowing for Point-of-Sale Rebates (Section 5)
The HIV+Hepatitis Policy Institute has long advocated for transparency and the direct pass-through of rebates. Manufacturer rebates and discounts have become a central feature of the prescription drug supply chain. In 2023 alone, total rebates and other price concessions for brand-name drugs reached approximately $334 billion across the U.S. market.[2] Requiring Caremark’s Standard Offering to enable members to receive the benefit of any rebate or discount at the point of sale, without additional pre-funding fees, represents an important step toward ensuring that negotiated savings reach patients directly. For individuals managing chronic conditions, even modest reductions in out-of-pocket costs can significantly improve medication adherence and financial stability. Allowing these savings to reach patients directly promotes greater transparency and helps correct incentives that have historically rewarded higher list prices.
Improving Transparency in the Prescription Drug Supply Chain (Sections 7 and 11)
The transparency requirements in Section 7 of the proposed order are a critical response to the systemic opacity identified in the FTC’s recent investigations into PBM pricing. By requiring automated, claim level reporting and the full disclosure of compensation paid to consultants or brokers, the settlement provides plan sponsors with the essential data needed to identify and mitigate extreme markups that have reached thousands of percent for certain lifesaving medications. Without this provision, plan sponsors would lack the verified data needed to ensure their members are actually paying the lower, negotiated price at the pharmacy counter.
Section 11 requires Caremark to maintain the operations of its group purchasing organization, Zinc Health Services, in the United States. Ensuring that GPO activities remain subject to domestic jurisdiction and U.S. transparency standards is important for continued regulatory oversight, particularly given the approximately $7.6 billion in annual fees GPOs now extract from manufacturers, a figure that has doubled since 2018.[3]
Additional Recommendations to Strengthen Patient Protections
While we strongly support the proposed order, we believe several additional protections could further strengthen its impact for patients.
First, the Commission should require Caremark to comply with the Court’s ruling in HIV and Hepatitis Policy Institute et al. v. HHS, No. 1:22-cv-02604 (D.D.C. 2023), by ensuring that manufacturer patient assistance provided on behalf of a patient counts toward that patient’s deductible and out-of-pocket maximum. Despite the Court’s ruling, PBMs and insurers continue to implement discriminatory copay accumulator adjustment programs. These practices effectively allow PBMs to collect the same payment twice: once from the manufacturer’s assistance and again from the patient. As a result, patients may still be responsible for thousands of dollars in additional out-of-pocket costs once that assistance is exhausted.
Twenty-six states, the District of Columbia, and Puerto Rico have enacted laws prohibiting these programs due to their harmful impact on patients, but those protections generally do not apply to individuals enrolled in ERISA-regulated employer health plans.[4] Requiring Caremark to count manufacturer assistance toward patient cost-sharing obligations would help ensure that these programs do not undermine the affordability protections the Commission seeks to advance.
Second, we are concerned that many of the patient protections in the proposed order apply only to Caremark’s “Standard Offering” rather than to all plans administered by the PBM. While the order appropriately requires employers to sign a waiver if they choose not to adopt the Standard Offering, employers may still be incentivized to select alternative plan designs that generate higher rebates but do not include the patient protections described in the order. The Commission should instead require that the patient protections described in the proposed order apply across all plans administered by Caremark. Applying these safeguards uniformly would prevent plan design choices from undermining the consumer protections contemplated in this order and ensure that patients receive consistent affordability protections regardless of the plan selected by their employer.
The provisions included in the proposed order represent important progress toward addressing longstanding concerns about the disconnect between the prices negotiated in the pharmaceutical supply chain and the costs patients face at the pharmacy counter. Incorporating the additional protections described above would further strengthen the order and help ensure that the benefits of these reforms are fully realized for patients.
HIV+Hep also encourages the Commission to ensure the forthcoming OptumRx settlement includes at least the same patient protections contained in this order and the Express Scripts settlement. The patient protections included in this proposed order would provide meaningful affordability improvements if applied broadly across the PBM market.
Thank you for the opportunity to comment on this important matter. If you have any questions or need any additional information, please do not hesitate to reach out to our Government Affairs Director, Zach Lynkiewicz, at zlynkiewicz@hivhep.org.
Sincerely,
Carl E. Schmid II
Executive Director
[1] HIV+Hepatitis Policy Institute et al., Ensuring Patient Access and Affordability Under TrumpRx, Letter to U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. (Nov. 26, 2025), https://hivhep.org/wp-content/uploads/2025/12/Patient-Group-Letter-Trump-Rx-Nov-2025.pdf.
[2] Kristi Martin, “What Pharmacy Benefit Managers Do, and How They Contribute to Drug Spending” (explainer), Commonwealth Fund, Mar. 17, 2025. https://www.commonwealthfund.org/publications/explainer/2025/mar/what-pharmacy-benefit-managers-do-how-they-contribute-drug-spending.
[3] Federal Trade Commission, Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies, Interim Staff Report, July 9, 2024. https://www.ftc.gov/system/files/ftc_gov/pdf/pharmacy-benefit-managers-staff-report.pdf.
[4] The AIDS Institute. Copay Accumulator Adjustment Programs: How Insurers Continue to Undermine Patient Assistance. Feb. 27, 2026. https://theaidsinstitute.org/media/documents/02-27-2026-09-23-55-TAI_2026_Report_final.pdf.