Comments to Senate Finance Comm. Democrats on private health coverage reform
Ranking Member
Committee on Finance
United States Senate
219 Dirksen Senate Office Building
Washington, DC 20510
Dear Ranking Member Wyden and Senate Finance Committee Democrats:
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 thank Ranking Member Wyden and Senate Finance Committee Democrats for the opportunity to comment on this Request for Information. We share your goal of ensuring that all Americans have access to affordable, comprehensive health coverage and urge Congress to restore recent reductions in coverage and affordability that impact both public and private health insurance programs.
The coverage expansions and consumer protections established by the Affordable Care Act are particularly important for people living with or at risk of HIV, hepatitis, and other serious and chronic health conditions. While we support universal access to affordable, comprehensive health coverage, this RFI focuses on reforms to private health insurance, which covers approximately 66% of Americans[1] and 35% of non-elderly adults living with HIV.[2] For these individuals, having an insurance card is not enough. Healthcare must be affordable and provide timely access to the prescription drugs, preventive services, laboratory testing, specialists, and other care necessary to prevent disease, maintain health, and avoid treatment interruptions. For infectious diseases such as HIV and viral hepatitis, access to effective treatment and prevention also reduces transmission and advances broader public health goals.
As the Committee considers reforms to private health coverage, we encourage a focus not only on maintaining coverage but also on ensuring that patients can afford and access the benefits it provides. Our comments below focus on several areas of the RFI that are particularly important to achieve that goal for people living with or at risk of HIV and hepatitis and others with serious or chronic health conditions.
Section 1: Reversing Cuts and Ensuring Affordable, Comprehensive Coverage
I. Protect Essential Health Benefits and Extend Comprehensive, Non-Discriminatory Coverage
People and communities affected by HIV, viral hepatitis and other serious and chronic conditions need meaningful, consistent, and non-discriminatory health insurance coverage. The Essential Health Benefits (EHB) framework makes this possible in ACA-compliant health insurance plans by ensuring that plans cover clinically appropriate care and treatment, and that covered care falls under the ACA’s cost-sharing, out-of-pocket maximum, and preventive care protections. Congress should preserve strong federal EHB requirements and reject efforts to weaken benchmark coverage, whether through changes that diminish formulary breadth or by narrowing what counts as an essential health benefit.[3] We also call on Congress to take the following steps:
a. Ensure that covered prescription drugs are always considered EHB
When a plan covers a prescription drug, that drug should be treated as an essential health benefit, and the patient should receive all protections connected to EHB, including having cost-sharing count towards the annual maximum out-of-pocket. CMS has articulated this principle in the individual and small group markets, clarifying by regulation that if a plan chooses to cover drugs beyond the number required by the state benchmark floor, all covered drugs are EHB. Though CMS stated that future rulemaking by the Departments will extend this clarification to large-group and self-funded plans, this has not yet taken place. This allows plans and their vendors to exploit this regulatory gap by classifying certain covered drugs as “non-EHB” in order to evade cost-sharing protections and implement harmful benefit designs such as copay maximizers and alternative funding programs (See Section 3.II below). We urge Congress to ensure that drugs covered beyond benchmark requirements are always considered EHB. (We discuss some additional EHB considerations in relation to state coverage mandates in our discussion of preventive coverage protections and HIV pre-exposure prophylaxis (PrEP) in Section 1.III below.)
b. Strengthen non-discrimination protections and ensure they are enforced across markets, including requiring formularies to follow clinical guidelines
Coverage must also be non-discriminatory. Under ACA rules, drug formularies may not discourage enrollment by any group of enrollees and must provide access to drugs included in broadly-accepted treatment guidelines that are indicative of current clinical best practice.[4] Since 2023, a non-discriminatory formulary for a plan providing EHB must be clinically-based.[5] For people living with HIV, this means that coverage, drug tiering, and utilization management must follow national guidelines such as DHHS HIV treatment guidelines or AASLD-IDSA hepatitis C clinical practice guidelines. Too often, however, we encounter plans with (a) inadequate formulary coverage of guideline-recommended drugs, including first-line regimens, (b) formularies that tier the majority of drugs for a particular condition on high-cost tiers (adverse tiering), or both. As we described in our comments on CMS’s Plan Year 2027 Letter to Issuers, tools currently provided by CMS to detect these two forms of discriminatory formulary coverage fall far short, allowing both adverse tiering and non-coverage even of guideline-recommended first-line treatments.[6] Some self-funded plans even completely exclude specialty drugs from coverage, leaving people with HIV, hepatitis and other serious conditions without coverage of any of the medications they need. This type of benefit design would be plainly discriminatory under EHB rules but is currently permitted in this market. Access to essential medications should not depend on whether their employer’s plan is fully-insured or self-funded. We urge Congress to ensure that non-discrimination protections apply across markets.
Clinical guidelines must also underpin medical necessity determinations. Some issuers deny long-acting antiretrovirals for HIV treatment and prevention with policies stating that they are “not medically necessary,” and treating them as a convenient alternative to daily oral medication. While long-acting options may well be convenient for many patients, they have significant clinical superiority. They are recommended in DHHS treatment guidelines, CDC PrEP guidelines, and by the USPSTF, among many other bodies. Long-acting PrEP has proven more effective than daily oral formulations in clinical trials,[7] and long-acting treatment has proven superior to oral therapy for people facing adherence challenges.[8] They also offer advantages for many people who struggle with unstable housing, stigma, confidentiality concerns, and incarceration. Congress should act to ensure that medical necessity determinations follow clinical guidelines and account for adherence, individual circumstances, and the judgment of the clinical provider.
Formulary and utilization management decisions should also be made transparently. Pharmacy and therapeutics committees should include meaningful patient representation, disclose conflicts of interest, and make public the clinical basis for their coverage, tiering, and utilization management decisions. Too often P&T decisions are not based on clinical criteria but rather on the level of rebates pharmacy benefit managers can extract from pharmaceutical manufacturers. Finally, because EHB non-discrimination standards only apply to plans offering EHB, Congress should act to ensure that these protections are extended to apply across all markets, including large group and self-funded plans. Congress should also reaffirm that Section 1557 of the ACA prohibits discriminatory benefit designs by covered health programs and ensure these protections are adequately enforced by regulators, including a fully funded HHS Office for Civil Rights.
c. Federal EHB rules should not discourage states from strengthening coverage
States are most familiar with their residents and their health needs, which is why federal rules allow state EHB benchmark plans to vary within specified bounds. States also often serve as laboratories of innovation. Under Section 1311(d)(3)(B) of the ACA, however, states must defray the cost of benefits they require beyond EHB benchmark coverage.[9] In our work supporting state legislation and regulation to backstop federal PrEP protections, we have seen states hesitate to act out of concern that codifying coverage protections could trigger defrayal obligations, even when a state is simply implementing or clarifying requirements that already exist under federal law.
Congress should halt CMS’s recent reactivation of defrayal pending a clarification of precisely which state actions trigger it. It should also clarify that state legislation or other actions that implement or clarify existing federal coverage requirements do not trigger defrayal. Congress should also take action to end the pause in the review of state EHB benchmark plan applications initiated in May 2026, which prevents states from updating their benchmarks to reflect current standards of care.
II. Affordable Coverage and Meaningful Financial Protection
Health insurance should provide meaningful protection from unaffordable costs. Even if a household may be able to afford their premiums, excessive out-of-pocket costs, including deductibles or coinsurance, often keep care out of reach for many.
This is particularly important for prescription drug coverage. In 2024, hospital care accounted for 31% of total US healthcare spending, compared with just 8.8% for prescription drugs. Yet patients pay a far higher share of prescription drug costs: out-of-pocket costs accounted for 11.8% of prescription drug spending, compared with just 2.5% of hospital costs.[10] This disparity reflects benefit designs that rely on deductibles, coinsurance, and high cost-sharing tiers that expose patients to inflated gross list prices. According to IQVIA, commercially insured patient out-of-pocket costs rose approximately 5% in 2025 alone and approximately 37% since 2020.[11] For people who depend on continuous access to medications, including people living with HIV, the design of the pharmacy benefit can have an outsized impact on whether that coverage is truly affordable. These costs are why manufacturer assistance is so critical for people with serious or chronic illness and why the benefit designs described in Section 3.II are so harmful.
Congress should act to require that patient cost-sharing for prescription drugs be based on the net price the plan actually pays, not the inflated list price. When patients pay coinsurance, or pay the full price during their deductible phase, their costs are calculated based on a list price that does not reflect the very substantial rebates and discounts plans and PBMs receive. This means that the patients with the highest drug costs end up subsidizing premiums for everyone else. As then-FDA Commissioner Scott Gottlieb succinctly stated in 2018, “Sick people aren’t supposed to be subsidizing the healthy.”[12] Plans should use predictable, fixed copays rather than coinsurance for prescription drugs, and patient cost-sharing should be capped at levels that are affordable. We also support standardized plan designs covering high-value services, such as HIV treatment or prevention, before the deductible, as well as the concept of exempting non-shoppable services from the deductible.
Congress should also oppose the expansion of short-term limited duration insurance and other junk insurance products not subject to ACA protections. These plans are particularly dangerous for people who rely on continuous access to medications and specialty care. Congress should codify limits on the duration and renewability of short-term plans and ensure they are not deceptively marketed.
III. Protect and Enforce Zero-Cost Preventive Services
Section 2713 of the Public Health Service Act, which requires coverage of recommended preventive services without cost-sharing, has been one of the most important achievements of the ACA. These preventive health protections are particularly important for people and communities affected by HIV and viral hepatitis, helping individuals protect their health while benefiting their partners and communities by reducing transmission and increasing screening. Congress should protect this requirement and ensure that the recommendations that trigger it remain grounded in gold-standard, independent review of the clinical evidence.
PrEP illustrates both the value of Section 2713 and the gap between the law and the experience of PrEP users and their clinical providers. PrEP was first given an “A” grade in 2019, when only a single drug, Truvada or emtricitabine/tenofovir disoproxil, was approved for PrEP. It was then updated in 2023 after the FDA approval of a second daily oral drug (Descovy or emtricitabine/tenofovir alafenamide) as well as the first long-acting injectable, Apretude (cabotegravir), which has a two-month dosing interval. Following advocacy by the HIV+Hepatitis Policy Institute and partner organizations, the Departments issued guidance in 2021 and again in 2024 making clear that plans must cover these FDA-approved PrEP medications, as well as the ancillary services, including HIV testing, STI testing, kidney function testing, hepatitis B and C testing, and associated office visits. The guidance further clarified that all the drugs and services must not be subject to cost-sharing or prior authorization to steer users to a particular drug.[13] The 2021 guidance states, and the 2024 guidance reiterates that the USPSTF PrEP recommendation “encompasses FDA-approved PrEP antiretroviral medications”. The USPSTF recommendation is not drug-specific and encompasses any FDA-approved PrEP formulation as an “A”-grade preventive service. Therefore, the long-acting PrEP drug, Yeztugo (lenacapavir), approved in June 2025, and future PrEP drugs should be covered as an ACA preventive service. This guidance applies to all non-grandfathered commercial insurance plans, as well as to Medicaid Alternative Benefit Plans.
In Medicare, the 2024 National Coverage Determination for PrEP, which is predicated on the USPSTF “A”-grade recommendation, requires no-cost coverage of all PrEP medications in Medicare Part B as well as ancillary services.[14]
In practice, compliance, while growing, has been inadequate and inconsistent. A 2023 report found widespread gaps in compliance with the zero-cost mandate across recommended preventive services. [15] We frequently learn of plans that improperly impose cost-sharing on PrEP medications, laboratory testing, or clinical visits, require prior authorizations or step therapy to steer PrEP users to a particular PrEP drug, or exclude newer PrEP drugs including long-acting formulations from coverage altogether. Studies have estimated that more than a third of all commercially insured PrEP users were improperly charged cost-sharing for PrEP drugs, and 20 to 30% were charged for ancillary services, with a mean cost of $222.[16]
In several recent cases, health insurance plans have shifted to compliant coverage of PrEP after we submitted formal complaints to regulators. These outcomes are welcome, but it should not take formal complaints from national advocacy organizations for PrEP users to receive the coverage the law already requires.
Congress should also end the delays that have repeatedly slowed no-cost access to innovative PrEP formulations. Coverage requirements should extend automatically to newly approved PrEP medications, without waiting for new USPSTF or federal guidance, which delays access to the latest scientific innovations by two to six years after FDA approval. Utilization management should not be allowed to direct PrEP users to a particular formulation.
Congress should strengthen enforcement of Section 2713 across all markets. Federal and state regulators should conduct proactive compliance reviews, including claims-level audits of preventive service cost-sharing, rather than relying on individual complaints. Enforcement should take place across markets, including among employer-sponsored and self-funded plans, where, as discussed in Section 2.II, oversight by the Department of Labor has been especially limited. Plans that impose cost-sharing should be required to reprocess claims and reimburse their members, meaningful penalties should be imposed, and these actions should be made public. Enforcement and penalties behind closed doors deter only the insurer involved, not the broader market.
We strongly support the PrEP Access and Coverage Act (S. 3990/H.R. 7853). The bill is led in the Senate by Senators Tina Smith and Adam Schiff, with 36 cosponsors including Ranking Member Wyden, Senator Cortez Masto, and Senator Peter Welch. The companion bill in the House is led by Representatives Mark Pocan, Becca Balint, and Mark Takano, with 162 cosponsors. It would require public programs and private health insurance plans, including grandfathered and self-funded plans, to cover all FDA-approved PrEP drugs and associated ancillary services without cost-sharing, and it would prohibit prior authorization, except for branded drugs with a generic equivalent. Because the bill ties coverage to FDA approval and current clinical guidelines, it would accomplish much of what we have recommended above. It would also fund much-needed PrEP programs for the uninsured. We urge Congress to enact it as quickly as possible.
Section 2: Making Health Care Simpler for Families
I. Reform Prior Authorization and Utilization Management
Prior authorization is overused, frequently inappropriate, and can impose serious burdens on patients, caregivers, and providers. A 2024 survey by the American Medical Association found that 93% of physicians report that PAs cause patient care delays, 82% say they can lead to treatment abandonment, and 29% reported that PA caused a serious adverse event in a patient’s care.[17] A 2025 IQVIA analysis substantiated these findings, showing that approximately 27% of all written prescriptions in the U.S. go unfilled due to insurance rejections, high costs, and PA issues.[18] These burdens are particularly concerning for people managing serious chronic conditions, including HIV and hepatitis, where delays and denials can lead to treatment gaps, drug resistance, and irreversible health consequences.
Voluntary insurer commitments are not a substitute for enforceable federal standards. Congress should establish clear limits on the use of prior authorization in private health insurance and prohibit its use for categories of care where delays pose particular clinical risks, including HIV treatment and prevention. This approach is not without precedent. Medicare Part D already prohibits prior authorization and step therapy for antiretroviral drugs.
Where prior authorization remains in place, the criteria should be evidence-based, grounded in current clinical guidelines, publicly available, and understandable to providers and patients. Plans should disclose before enrollment which covered drugs and services require prior authorization, the specific clinical criteria that must be satisfied, and the documentation required to support a request. Patients should not learn these requirements only after a prescription or service has been denied. A 2025 survey of 1,000 patients found that more than half reported needing to take additional steps such as phone calls or repeating tests to obtain medications through the PA process, and one third reported that PA delays led to worse health outcomes.[19]
Federal standards should also establish firm decision timelines and meaningful consequences when plans fail to meet them. For other high-priority therapies where prior authorization remains permissible and delays pose significant clinical risks, requests should qualify for expedited review by default. When a plan misses a federally required decision deadline, the request should be deemed approved or, at minimum, the patient should receive an emergency supply sufficient to bridge the gap until a decision is made.
Reporting requirements should also move beyond aggregate statistics. Plans should report prior authorization data by drug or service and clinical category, including approval and denial rates, appeals and reversals, and processing times. Aggregate reporting can obscure significant differences across treatments and clinical areas, including unusually high denial rates or delays for particular drugs or services, making it difficult to identify where prior authorization is creating barriers to care.
Patients should also be protected when they change coverage. Plans should honor active prior authorization approvals from a patient’s prior plan for a mandatory transition period of at least 30 to 60 days, during which the new plan may conduct its own review but may not interrupt access to the patient’s existing treatment. At least 10 states passed PA reform legislation in 2024 and at least 18 more took legislative action in 2025, many including provisions requiring plans to honor PAs during coverage transitions, confirming that mandatory continuity protections are practically achievable.[20]
Finally, as insurers increasingly use artificial intelligence and automated tools in utilization review, technology should be used to reduce administrative burden, not to independently make adverse coverage determinations. Any denial should receive meaningful review by a qualified clinical professional, and automated systems should be subject to oversight for discriminatory patterns or systematically inappropriate denials. The same principle should apply to any algorithm used to identify cases for heightened utilization management, as efficiency should not come at the expense of individualized clinical review.
These recommendations are consistent with comments HIV+Hep recently submitted to the Centers for Medicare & Medicaid Services on proposed reforms to prior authorization in Medicare, which similarly called for stronger federal standards to reduce delays and improve transparency, accountability, and continuity of care.[21]
II. Improve Accountability and Consumer Protections in ERISA/Self-Funded Plans
The majority of people with employer-sponsored coverage are enrolled in self-funded plans, yet these plans are subject to the weakest requirements and oversight in the health insurance system. A recent Department of Labor Inspector General report found that the Employee Benefits Security Administration, which oversees an estimated 2.8 million health, retirement, and other benefit plans covering 153 million people, had less than one investigator for every 12,600 plans in 2023.[22] EBSA’s enforcement is largely reactive and complaint-driven, and DOL lacks authority to impose financial penalties for most violations of federal coverage requirements.[23]
The consequences of weak oversight are visible in our work. The preventive services violations discussed in Section 1.III, including improper cost-sharing for PrEP medications, laboratory tests, and clinical visits, frequently arise in self-funded plans, where enrollees have no state regulator to turn to and DOL rarely acts. Self-funded plans are also where copay maximizers and alternative funding programs, discussed in Section 3.II, have taken hold. Congress should give EBSA the resources and penalty authority needed to enforce the law and require proactive compliance reviews with public reporting of findings.
Congress should also ensure that the prior authorization, nondiscrimination, preventive services, and formulary protections discussed in these comments apply without regard to whether an employer is fully insured or self-funded. Employees and their family members deserve meaningful external review rights and remedies. Under ERISA, a plan that wrongfully denies care is usually liable for little more than the cost of the benefit it should have provided,[24] and most state law claims are usually preempted. Insurers and PBMs that design and administer self-funded plans should not escape responsibility for compliance simply because the employer bears the financial risk.
Finally, ERISA preemption limits states’ ability to protect residents enrolled in self-funded plans, making federal protections and enforcement essential. Preemption is not absolute, however. In Rutledge v. PCMA, the Supreme Court confirmed that states may regulate PBMs serving ERISA plans, and we support states building on that authority.
Section 3: Taking on Corporate Greed
I. Address Vertical Integration, PBM Conflicts, and MLR Gaming
We share the concerns discussed in the RFI about the impact of vertical integration and the financial incentives created when insurers own PBMs, pharmacies, group purchasing organizations (GPOs), providers, and other healthcare entities. These incentives can negatively impact patients when decisions about formulary placement, benefit design, and access to medications are influenced by the rebates, fees, and other revenue generated by affiliated companies. The magnitude of these financial flows is substantial. In 2023, drug manufacturers paid an estimated $334 billion in rebates and other price concessions to PBMs and insurers.[25] The Federal Trade Commission has also estimated that manufacturers pay approximately $7.6 billion annually in fees to GPOs affiliated with the three largest PBMs, more than double the amount paid in 2018.[26] Recent FTC enforcement actions against the three largest PBMs and their affiliated GPOs further demonstrate concerns about how these incentives can affect patients. We supported the reforms included in the resulting settlements while recommending that they go further to reduce conflicts between PBM financial incentives and patient access and affordability.[27]
Congress should require greater transparency around transactions among affiliated insurers, PBMs, pharmacies, providers, GPOs, and other entities. Reporting should capture rebates, administrative fees, and other forms of direct and indirect compensation received and retained throughout the corporate structure. Greater transparency is necessary to prevent revenue from being shifted among affiliated entities in ways that obscure actual profits and the true cost of providing health coverage.
These concerns should also be addressed through stronger medical loss ratio requirements. Payments from an insurer to an affiliated PBM, pharmacy, provider, or other entity should not automatically be treated as spending on patient care when a portion of those payments ultimately remains within the same corporate organization. MLR reporting should provide greater transparency into intercompany transactions and rebates and ensure that the calculation reflects the amount actually spent providing healthcare to patients rather than amounts transferred among corporate affiliates.
II. End Benefit-Design Practices That Shift Costs onto Patients, Charitable Sources, or Manufacturers
Health insurance should protect patients from unaffordable costs when they need care. Yet plans and PBMs increasingly develop and use complex schemes that shift the cost of covered prescription drugs onto patients, manufacturers, charities, and other outside sources. Copay accumulator programs, copay maximizers, and alternative funding programs operate differently, but they share a common result. They extract more from patients or the financial assistance intended to help them afford their medications while reducing what plans pay. More importantly, these schemes can delay or, in some cases, prevent patients from accessing the medications they need.
Copay assistance plays an especially important role for people with serious and chronic conditions who often can only be effectively treated with specialty medications that carry significant out-of-pocket costs. According to IQVIA, patients with copay assistance abandon prescriptions at the pharmacy 8% of the time, compared with 14% for patients without assistance. Patients receiving assistance are also adherent to their medications for an average of 202 days per year, compared with 102 days for those without assistance.[28] Copay accumulator programs undermine these benefits by preventing manufacturer copay assistance provided on behalf of a patient from counting toward the patient’s deductible and annual out-of-pocket maximum. Copay maximizers aim to capture all available manufacturer copay assistance by manipulating specialty drug cost sharing to coerce patients to enroll in these programs while denying them credit toward their deductibles and annual out-of-pocket maximums.
These schemes have become widespread. Copay assistance totaled $23 billion in 2025, yet $7 billion is being used by programs that do not count that assistance toward patient cost sharing.27 In 2024, an estimated 43% of commercially insured lives were enrolled in plans that had implemented copay accumulator programs.[29] That assistance is intended to reduce financial barriers for patients, not to become a revenue source for plans and their intermediaries.
Three years ago, HIV+Hep, three patients, and two diabetes organizations successfully challenged a federal rule that allowed health plans to decide whether copay assistance counts toward a patient’s annual cost-sharing limits.[30] The court struck down that policy, leaving in effect the 2020 federal rule requiring manufacturer assistance to count when no medically appropriate generic equivalent is available. Yet the federal government has not enforced the court decision or issued the new rule it previously indicated it would pursue. While 26 states, the District of Columbia, and Puerto Rico have enacted laws requiring insurers to count copay assistance toward patient cost sharing, these protections generally cannot reach self-funded employer plans. Congress should establish a clear federal standard requiring all copay assistance used by or on behalf of a patient to count toward the patient’s deductible and annual out-of-pocket maximum.
Alternative funding programs take this cost shifting even further. Like copay maximizers, these arrangements may remove specialty drugs from the plan benefit or designate them as non-essential. Alternative funding programs then go further by directing patients to seek medication through manufacturer patient assistance programs for the uninsured, charitable programs, AIDS Drug Assistance Programs, illegal importation,[31] or other mechanisms outside the insurance benefit. If patients do not participate, they are left responsible for the full cost of the medication. Plans should not be permitted to reclassify or carve out covered prescription drugs as non-EHB or require patients to obtain those drugs from outside sources. Congress should close this loophole across markets and prohibit copay maximizers and alternative funding programs that evade ACA cost-sharing and coverage protections. Congress should also investigate the growing use of these harmful schemes and their impact on patient costs and access to medications.
Addressing copay accumulators without closing the non-EHB loophole would create an incentive for plans and PBMs to shift toward copay maximizers or other arrangements that exclude drugs from essential health benefits. Conversely, closing the non-EHB loophole without requiring copay assistance to count toward patient cost sharing would leave copay accumulators as an alternative means of capturing that assistance without providing patients credit toward their annual limits. Congress must address both practices to prevent plans and PBMs from simply substituting one cost-shifting scheme for another.
III. Protect Patients Using Direct-to-Consumer Drug Programs
Direct-to-consumer programs may provide important savings for some patients, but they should not become a substitute for affordable prescription drug coverage. When an insured patient can purchase a covered medication for less by bypassing their insurance altogether, it raises a fundamental question about whether the prescription drug benefit is providing meaningful value. Federal policy should ensure that plans and PBMs do not use direct-to-consumer programs to shift covered prescription drug costs outside the insurance benefit while patients continue to pay premiums for coverage that does not provide them with the lowest available price.
These concerns are different for uninsured patients and others who lack adequate prescription drug coverage, for whom direct-to-consumer programs may provide important savings and access to medications. However, for insured patients, comparing a direct-to-consumer cash price only with their immediate cost sharing under insurance can be misleading. A lower price at the pharmacy may ultimately cost a patient more over the plan year if the payment does not count toward their deductible or annual out-of-pocket maximum. This is particularly important for people with serious and chronic conditions who use multiple medications and healthcare services and may be more likely to reach their annual out-of-pocket maximum. HIV+Hep and 18 other patient organizations have raised these concerns since TrumpRx was first announced.[32]
Patients should therefore be clearly informed whether a direct-to-consumer purchase will count toward their deductible and annual out-of-pocket maximum. More importantly, when an insured patient purchases a covered medication through TrumpRx or another direct-to-consumer program at a lower price than they would pay through their plan, the amount they pay should count toward those cost-sharing protections. Express Scripts and CVS Caremark have already agreed through their respective FTC settlements to count qualifying TrumpRx purchases toward deductibles and out-of-pocket maximums for covered drugs, although those commitments are conditioned on future regulatory changes. These protections should apply consistently across the commercial insurance market rather than depend on voluntary commitments by individual PBMs.
Federal regulators should also examine how direct-to-consumer purchasing of covered drugs affects medical loss ratio calculations, actuarial value, and premiums. If a plan or PBM encourages patients to purchase covered drugs outside the insurance benefit, the plan avoids costs it otherwise would have incurred. Those reduced expenditures should be appropriately reflected in regulatory filings and should not allow plans to benefit financially by shifting covered prescription drug spending outside the insurance benefit.
Conclusion
We thank the Senate Finance Committee Democrats for the opportunity to comment on this RFI and for your continued focus on improving health coverage and affordability. As Congress considers reforms to private health insurance, we urge you to ensure that coverage provides meaningful access to the medications, services, and care patients need and protects them from practices that shift costs or create unnecessary barriers to treatment. We hope to serve as a resource as you continue considering these important issues. If you have any questions or need any additional information, please contact our Government Affairs Director, Zach Lynkiewicz, at zlynkiewicz@hivhep.org, or our Health Policy Director, Kevin Herwig, at kherwig@hivhep.org.
Sincerely,
Carl E. Schmid II
Executive Director
cc: The Honorable Catherine Cortez Masto
The Honorable Peter Welch
The Honorable Ruben Gallego
[1] U.S. Census Bureau, Health Insurance Coverage in the United States: 2024 (Sept. 9, 2025), https://www.census.gov/library/publications/2025/demo/p60-288.html.
[2] Kaiser Family Foundation (KFF), “Medicaid and People with HIV” (2023) and “Insurance Coverage and Viral Suppression Among People with HIV,” analyzing CDC Medical Monitoring Project (MMP) data. https://www.kff.org/hiv-aids/medicaid-and-people-with-hiv/.
[3] HIV+Hepatitis Policy Institute et al, Letter from 96 Patient and Consumer Organizations to Administrator Oz in Response to the Request for Information on Essential Health Benefits [CMS-9874-NC] (July 15, 2026), https://hivhep.org/wp-content/uploads/2026/07/EHB-Sign-on-Letter-7.15.26.pdf.
[4] 45 CFR 156.122(a)(3)(iii)(H); 45 CFR 156.225(b)
[5] 45 CFR 156.125(a)
[6] HIV+Hepatitis Policy Institute, Comments on the 2027 Draft Letter to Issuers in the Federally-facilitated Exchanges (March 23, 2026), https://hivhep.org/wp-content/uploads/2026/03/Comment-on-2027-Letter-to-Issuers-3.23.26.pdf.
[7] HIV Prevention Trials Network, HPTN 083, https://www.hptn.org/research/studies/hptn-083; HPTN 084, https://www.hptn.org/research/studies/hptn-084; Gilead Sciences, PURPOSE Clinical Trial Program, https://www.purposestudies.com/.
[8] AIDS Clinical Trials Group, A5359 (LATITUDE): Long-Acting Antiretroviral Therapy in Non-Adherent Persons Living with HIV, https://actgnetwork.org/clinical-trial/actg-a5359-long-acting-antiretroviral-therapy-in-non-adherent-persons-living-with-hiv-plwh/.
[9] Héctor Hernández-Delgado & Wayne Turner, National Health Law Program, State-Mandated Benefits and ACA Defrayal Obligations (August 6, 2026), https://healthlaw.org/resource/state-mandated-benefits-and-aca-defrayal-obligations/.
[10] Centers for Medicare & Medicaid Services, National Health Expenditure Data: Historical, NHE Tables, Tables 7 and 16, https://www.cms.gov/files/zip/nhe-tables.zip.
[11] IQVIA, Cost of Access: Patient Affordability Now Shapes Utilization (Sept. 10, 2026), https://www.iqvia.com/locations/united-states/blogs/2026/08/cost-of-access-patient-affordability-now-shapes-utilization.
[12] CNBC, FDA Commissioner to Health Insurers: You’re Doing It Wrong (March 7, 2018), https://www.cnbc.com/2018/03/07/fda-commissioner-to-health-insurers-youre-doing-it-wrong.html.
[13] Departments of Labor, Health and Human Services & Treasury, FAQs About Affordable Care Act Implementation Part 68 (July 19, 2021), https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-47.pdf; FAQs About Affordable Care Act Implementation and Women’s Health and Cancer Rights Act Implementation Part 68 (October 21, 2024), https://www.cms.gov/files/document/faqs-implementation-part-68.pdf.
[14] Centers for Medicare & Medicaid Services, National Coverage Determination: Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Infection Prevention 210.15 (2024), https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=377&ncdver=1.
[15] Consumer Representatives to the National Association of Insurance Commissioners, Preventive Services Coverage and Cost-Sharing Protections Are Inconsistently and Inequitably Implemented: Considerations for Regulators (August 2023), https://healthyfuturega.org/ghf_resource/preventive-services-coverage-and-cost-sharing-protections-are-inconsistently-and-inequitably-implemented/.
[16] W. Zachry et al, Impact of the United States Preventive Task Force Guidelines on Pre-Exposure Prophylaxis (PrEP) Claims and HIV-1 Infection Incidence: An Interrupted Time Series with Segmented Regression Analysis. AMCP Nexus 2023, J. Managed Care & Specialty Pharmacy, Vol. 29, No. 10-a (Oct. 2023), https://www.jmcp.org/pb-assets/Supplements/2023%20Nexus%20Poster%20Abstract%20Supplement-1696348494.pdf; and Ya-Lin A. Huang et al, Out-of-Pocket Payments for PrEP Ancillary Services Among US Commercially-Insured Persons, 2017-2022. Poster 1117, Conference on Retroviruses and Opportunistic Infections (2024), https://www.croiconference.org/wp-content/uploads/sites/2/posters/2024/1117.pdf.
[17] American Medical Association. 2024 Prior Authorization Physician Survey. December 2024. Available at: ama-assn.org.
[18] IQVIA Institute for Human Data Science, Understanding the Use of Medicines in the U.S. 2025 (IQVIA, 2025), iqvia.com.
[19] DrFirst. 2025 Prior Authorization Patient Survey. Survey of 1,000 U.S. patients. Available at: drfirst.com (January 2026).
[20] American Medical Association / Georgetown Center on Health Insurance Reforms. Prior authorization state legislation tracker, 2024-2025. Available at: ama-assn.org and chir.georgetown.edu.
[21] HIV+Hepatitis Policy Institute, Comments to Administrator Oz on the CMS Proposed Rule on Interoperability Standards and Prior Authorization for Drugs (June 15, 2026), https://hivhep.org/testimony-comments-letters/comments-to-administrator-oz-on-the-cms-proposed-rule-on-interoperability-standards-and-prior-authorization-for-drugs/.
[22] U.S. Department of Labor, Office of the Inspector General, Top Management and Performance Challenges (Nov. 2023), p. 33-34, https://www.oig.dol.gov/public/DOL%202023%20Top%20Management%20and%20Performance%20Challenges.pdf.
[23] U.S. Government Accountability Office, Employee Benefits Security Administration: Systematic Process Needed to Better Manage Priorities and Increased Responsibilities, GAO-24-105667 (Oct. 24, 2023), https://www.gao.gov/assets/d24105667.pdf.
[24] 29 USC 1132(a)(1)(B)
[25] 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.
[26] 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.
[27] HIV+Hepatitis Policy Institute, 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. (Sept. 1, 2026), https://hivhep.org/testimony-comments-letters/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/.
[28] IQVIA, Cost of Access: Patient Affordability Now Shapes Utilization (Sept. 10, 2026), https://www.iqvia.com//locations//united-states//blogs//2026//08//cost-of-access-patient-affordability-now-shapes-utilization.
[29] Adam J. Fein, Why Plan Sponsors and PBMs Are Still Falling Hard for Copay Maximizers, Drug Channels (Feb. 12, 2025), https://www.drugchannels.net/2025/02/why-plan-sponsors-and-pbms-are-still.html.
[30] HIV+Hepatitis Policy Institute, Three Years Since Court Victory & Prescription Drug Copay Assistance Still Not Counting for Patients (Sept. 22, 2026), https://hivhep.org/press-releases/three-years-since-court-victory-prescription-drug-copay-assistance-still-not-counting-for-patients/.
[31] Bertha Coombs, Feds Warn Employers Some Health Plans May Be Breaking the Law on Prescription Drugs, CNBC (Nov. 13, 2025), https://www.cnbc.com/2025/11/13/employer-health-plans-afp-prescriptions-feds-illegal.html.
[32] HIV+Hepatitis Policy Institute et al., Patient Group Letter to Secretary Kennedy on Ensuring Patient Access and Affordability Under TrumpRx (Dec. 2025), https://hivhep.org/testimony-comments-letters/patient-group-letter-to-sec-kennedy-on-ensuring-patient-access-and-affordability-under-trumprx/.