Comments to CCIIO on the 2027 Draft Letter to Issuers in the Federally-Facilitated Exchanges
Deputy Administrator and Director
Center for Consumer Information
& Insurance Oversight
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201
Dear Administrator Nelson:
The HIV+Hepatitis Policy Institute, a leading national policy organization promoting quality and affordable healthcare for people and communities affected by HIV, viral hepatitis, and other serious and chronic health conditions, is pleased to offer comments on the 2027 Draft Letter to Issuers in the Federally-facilitated Exchanges.
Since we submitted comments on the Notice of Benefits and Payment Parameters for 2027 Proposed Rule, we will not repeat them here. However, we would like to reiterate our opposition to a number of proposed actions that affect insurance access and affordability, including Network Adequacy (Chapter 2, Section 3); and Essential Community Providers (Chapter 2, Section 4). We also emphasized two topics that were not addressed in the proposed rule–ensuring copay assistance counts as beneficiary cost-sharing and the requirement that all covered drugs must be considered essential health benefits for all types of plans.
The focus of our comments will be Discriminatory Benefit Designs (Chapter 2, Section 10), but we also wish to comment briefly on the continued use of Copay Maximizers in Marketplace plans.
Copay Maximizers
We strongly supported CMS’s action in the 2025 NBPP to close the Essential Health Benefit (EHB) loophole in the individual and small group markets by requiring all covered drugs to be classified as EHB. However, we continue to receive reports of Marketplace plans using copay maximizers, which rely on designating covered drugs as non-EHB. We have identified at least one issuer that appears to employ a copay maximizer on the Federally-facilitated Marketplace: Highmark, an issuer of plans in West Virginia and other states.[1] Its HCR Essential formulary, offered in West Virginia, uses a copay maximizer (implemented by PillarRx’s Copay Armor program) on fifteen antiretroviral drugs, including six of the eight guideline-recommended first-line regimens, and ten out of thirteen single-tablet regimens. Although our findings focus on antiretrovirals, a cursory search for several frequently prescribed high-cost medications in other therapeutic areas found many drugs impacted by copay maximizer coverage, including Stelara and Entyvio (immunology), Trikafta (cystic fibrosis), Cosentyx and Enbrel (psoriasis) and Mavyret and Vosevi (hepatitis C). The full extent to which Highmark resorts to impermissible copay maximizer coverage across the formulary is difficult to assess, as the searchable online formulary requires subclass-by-subclass search, whereas the online formulary document does not indicate which drugs are accessed through Copay Armor. We urge CMS to conduct robust enforcement of this important new protection, and to provide guidance to state regulators on how to ensure that plans designating covered drugs as non-EHB do not pass QHP review.
Chapter 2, Section 10: Discriminatory Benefit Design
CMS’s QHP review tools fail to prevent benefit designs that systematically deter enrollment of people living with HIV. We will highlight the way two specific tools fall short of their stated goals:
- Non-Discrimination Clinical Appropriateness Review Tool: Current coverage thresholds fall far short of both HHS treatment guideline recommendations and existing state EHB benchmark floors, leaving large patient populations without access to clinically appropriate treatment options.
- Adverse Tiering Tool: By evaluating tier placement only for a narrow set of covered single-tablet regimens (STRs), the tool permits issuers to place the vast majority of antiretrovirals on the highest-cost tiers without triggering review, enabling explicitly prohibited discriminatory cost-sharing patterns.
CMS’s Non-Discrimination Clinical Appropriateness Review Tool Allows Inadequate Coverage
Under ACA rules, formularies may not discourage enrollment by any group of enrollees, and must provide appropriate access to drugs included in broadly accepted treatment guidelines and that are indicative of general best practices at the time.[2] Since 2023, a non-discriminatory benefit that provides essential health benefits (EHB) must be clinically-based.[3] For people living with HIV, this means that coverage should follow the recommendations in broadly accepted clinical guidelines, such as the United States Department of Health and Human Services (HHS) HIV treatment guidelines, and should meet the patient needs reflected in the guideline recommendations.
To meet this standard, CMS provides as part of the annual QHP review process the Non-Discrimination Clinical Appropriateness Tool in order to ensure that issuers cover sufficient numbers and types of drugs to effectively treat certain conditions, including HIV.[4]
The tool is updated frequently. The version provided for the 2026 Plan Year specifies the following minimum thresholds for formulary coverage among various classes of antiretrovirals:
One change since the tool for the 2025 Plan Year is the reclassification in the Single-Tablet Regimen (STR) category: rather than requiring coverage of a minimum of three STRs, the updated tool splits the class into six “First-Line” regimens and six “Other” regimens, with new minimum coverage requirements of two First-Line STRs and one Other STR. While we thank CMS for this modification as a step towards reflecting guideline recommendations, these standards do not provide a meaningful or adequate threshold for coverage of antiretrovirals. Consider the following:
The standards allow for non-coverage even of first-line regimens
A critically important patient population is those who are newly diagnosed with HIV, or are beginning HIV treatment for the first time. HHS guidelines recommend four “preferred” regimens for use as first-line regimens in most people with HIV, as well as four “alternative” regimens for use in certain clinical situations.[5] Current CMS thresholds do not require coverage of all eight first-line regimens, only of two of the first-line regimens that are available as STRs. This means that a compliant formulary may leave substantial populations of patients initiating care without access to the treatment option that suits their clinical needs.
The standards do not address any clinical considerations beyond first-line regimens and STRs.
HHS guidelines recognize a broad range of second-line, third-line, and salvage regimens for those who have experienced virologic failure, developed resistance mutations, have comorbidities or drug-drug interactions, or cannot tolerate first-line regimens. None of these clinical considerations are reflected in the CCIIO coverage thresholds.
One noteworthy gap is people with HIV who are aging, a sizable and growing population for whom comorbidities, renal concerns, bone density issues, and polypharmacy interactions are clinical considerations that should unquestionably be reflected in formulary design. The following are just some of the more significant additional gaps, though they are by no means an exhaustive list:
- Tenofovir-based regimens.
Many widely used treatment regimens are built on a tenofovir backbone, with two distinct formulations: tenofovir alafenamide (TAF) and tenofovir disoproxil (TDF). These are not clinically interchangeable— TAF offers advantages for bone density and renal function, while TDF has advantages with respect to metabolic outcomes and weight gain. A formulary that provides no meaningful access to TAF-based regimens, such as the Community Health Choice Texas discussed below, is one that does not reflect guideline recommendations for substantial populations including many older people with HIV, and deters enrollment of people with HIV.[6]
- Long-acting regimens
Cabotegravir plus rilpivirine (Cabenuva) is the first complete long-acting regimen approved for HIV treatment and is recommended in HHS guidelines, particularly for patients with adherence challenges associated with daily oral dosing. Additional long-acting formulations are in development. As new formulations are approved, CMS should recognize the many patients with adherence challenges as a patient category whose needs should be reflected in non-discriminatory coverage category thresholds.[7]
- Previous guideline iterations
Treatment guidelines are updated frequently, and the set of recommended regimens shifts over time. Patients who are stable and virologically suppressed on a regimen that has since been removed from guideline recommendations or whose regimen is no longer preferred should not face coverage loss or be forced to switch regimens. CMS thresholds should establish a generous transition period during which drugs recommended in prior guideline iterations retain coverage protections.
These gaps are significant, affecting large and well-defined patient populations whose needs are predictable and well-documented in the guidelines.
Insurers sometimes assert that they provide appropriate access to medically necessary treatments through the exceptions process. We do not believe that substandard and discriminatory coverage can be excused by citing the exceptions process, which is mandatory. The exceptions process is a vital component of appropriate coverage–for infrequently prescribed regimens, not for regimens which are predictably required for substantial subpopulations based on guideline recommendations. Using the exceptions process to provide access to drugs required by substantial subpopulations is burdensome and imposes unacceptable delays to therapy, and shifts decision-making from clinicians to insurers.
The standards in most cases do not exceed the standard set by EHB benchmarks
Notably, the thresholds in CMS’s Clinical Appropriateness tool do not even reach the floors already defined by state EHB benchmark plans. State EHB benchmarks require coverage of between 10 and 18 NRTIs; CMS thresholds require coverage of only two. Benchmark plans in all but one state (Idaho) require coverage of protease inhibitors, with minimums ranging from 8 to 11 drugs, meaning that CMS’s Clinical Appropriateness standard, which requires coverage of just one protease inhibitor, has a meaningful effect on coverage of protease inhibitors only in Idaho, and a minimal one at that.
In total, current CMS Clinical Appropriateness thresholds require coverage of only 15 antiretrovirals across all twelve classes for which thresholds are specified. By contrast, state benchmarks require coverage of between 27 antiretrovirals across all classes in Hawaii[8] to 48 in Illinois[9]– again leaving aside Idaho as an extreme outlier requiring coverage of only 12 antiretroviral drugs.[10] Because several of the five drug classes distinguished in EHB benchmark thresholds do not map neatly to the twelve classes for which CMS Clinical Appropriateness thresholds are specified, precise class-by-class comparison is difficult. But the aggregate picture is clear: state EHB benchmarks are setting minimum ARV coverage standards, with CMS thresholds not adding much in terms of meaningful requirements.[11]
EHB benchmarks were selected to represent typical employer-sponsored insurance coverage, not to reflect the clinical complexity of HIV treatment guidelines. If CMS standards for non-discriminatory coverage fall well short of EHB benchmark floors that were never meant to reflect clinically appropriate care, it is time to anchor those coverage standards in the patient needs reflected in current, frequently updated guideline recommendations.
We urge CCIIO to increase the coverage thresholds in the Non-Discriminatory Clinical Appropriateness Tool such that they meaningfully incorporate regimens recommended for substantial patient populations in evolving clinical guidelines, ensuring that coverage keeps pace with scientific innovation and clinical best practice.
CMS’s Adverse Tiering Tool Allows Most Drugs for the Treatment of HIV to be Placed on High-Cost Tiers
CMS’s Adverse Tiering Tool is designed to assess whether a plan places all or a majority of drugs for the treatment of a health condition on the highest-cost tiers, a benefit design that has been recognized as presumptively discriminatory by CMS since 2015.[12] Yet the tool’s current parameters fail to identify many common and harmful patterns of adverse tiering in HIV drug coverage. The tool tests for adverse tiering of single-tablet regimens only, omitting consideration of the far more numerous single-ingredient drugs and combination drugs that do not constitute a complete treatment regimen. Since CMS’s Clinical Appropriateness review tool requires coverage only of three STRs, a QHP covering the minimum of three STRs should allow a formulary that covers all but two antiretroviral drugs on the highest-cost tier to pass Adverse Tiering review, as long as two STRs are covered on a lower tier.
We have heard from state insurance regulators that even formularies that place all but one antiretroviral medication on the highest-cost tier can pass Adverse Tiering review. CMS has stated in the past that plans are flagged for adverse tiering only when they place all drugs for the treatment of a particular condition on the highest-cost tier, rather than the majority of drugs on a high-cost tier (a recent example is the draft 2025 Letter to Issuers). If the standard implemented by the review tool is indeed all drugs, that would enable formularies that adversely tier all but one drug to pass review, making a mockery of the law and CMS’s determination that adverse tiering is presumptively discriminatory.
Data from Iowa illustrate this point starkly: Medica placed 84 percent of all covered antiretrovirals on the highest cost‑sharing tier, compared to between 2 and 8 percent for other issuers on the same Marketplace. Even among first‑line regimens, Medica covered only three of the eight “preferred” and “alternative” combinations recommended in federal treatment guidelines—fewer than any other Iowa issuer—yet it still met CMS’s existing tests for both adverse tiering and clinical appropriateness:
Importantly, the Iowa Insurance Division (IID) itself concluded that CMS’s Adverse Tiering Tool does not accurately reflect the agency’s own guidance. In its August 29, 2025, response to HIV+Hep, IID noted that a plan may “meet” CMS requirements if even one drug is not on the highest‑cost tier, despite CMS guidance that “all or a majority” of drugs placed on the top tier may be discriminatory. IID explicitly recognized that “the guidance and the tool are not aligned with each other,” and has sought clarification from CMS on this mismatch.
A meaningful adverse tiering review must look beyond a handful of STRs. CMS must revise its tool to evaluate tier placement across all clinically relevant antiretrovirals—including multi‑tablet and first-line regimens.
To simplify our own assessments of adverse tiering, we focused on the highest-cost tier, rather than all high-cost tiers. But we found many examples where a reviewer must look at the highest-cost tiers. The two examples below from Iowa and Minnesota demonstrate that one cannot only examine drugs placed on the highest-cost tier:
- Medica offers many plans in which tier 4 is associated with 50% coinsurance while tier 5 is associated with 60% coinsurance. While there is a difference between these two tiers, we believe covering all antiretrovirals on two very high-cost coinsurance tiers still constitutes adverse tiering. [13]
- Several issuers on both state Exchanges offer plans which charge a low copay for generics, but 50% coinsurance for all medications on the preferred, non-preferred, and specialty tiers.[14] We believe all of these plans engage in adverse tiering since they place all ARVs, STRs, and first-line regimens on tiers that result in high cost-sharing.
We urge CCIIO to update the Adverse Tiering Tool so that it ensures that issuers cannot place the majority of covered medications on a high-cost tier, rather than allowing these protections to apply to as few as one medication. We also urge CCIIO to reaffirm that adverse tiering occurs when the majority of drugs for a particular condition are placed on a high-cost tier, rather than when all drugs are placed on the highest-cost tier.
Real-Life Examples of Discriminatory Benefit Design
In our comments on the 2025 Letter to Issuers, we gave three real-life examples of discriminatory benefit design that discourage enrollment by people with HIV. We would like to update these examples to include developments over the past year and the role played in these cases by CMS review tools:
- Harvard Pilgrim Health Care
In November 2024, we filed discrimination complaints against Harvard Pilgrim in Maine, New Hampshire, and Rhode Island regarding clinically inappropriate coverage in its 2025 “Core 5 Tier” formulary, which eliminated coverage of thirteen previously covered antiretrovirals, including several frequently prescribed guideline-recommended first-line and single-tablet regimens.
In December, we received a response from Rhode Island’s Office of the Health Insurance Commissioner (OHIC) indicating that Harvard Pilgrim’s 2025 formularies had been validated by CMS’s Formulary Review Suite template, and noted that OHIC did not have the capacity to opine on the clinical appropriateness of an issuer’s formulary as long as it met state benchmarks and complied with state and federal law, and pointing to the formulary exception process for non-covered medications. OHIC also indicated that Harvard Pilgrim would grandfather coverage for current enrollees who were losing coverage of their HIV regimen.
Later that month, we received word from Maine’s Bureau of Insurance that after an investigation, Harvard Pilgrim would reverse the changes. The Bureau’s Superintendent stated publicly that he had pushed for this change, which was implemented in all three states, and that he appreciated the role of advocates and providers in bringing the matter to the Bureau’s attention.[15]
We did not receive any response from New Hampshire regulators.
- Medica
In November 2024, we filed discrimination complaints against Medica in Iowa and Minnesota for clinically inappropriate coverage and adverse tiering. The Iowa Insurance Department (IID) responded indicating the Department had found Medica to be in compliance with requirements after the issuer had provided information showing that it had made HIV treatments available that were not on the highest cost-sharing tiers and that it met the minimum standards for HIV treatment guidelines. We followed up with a more detailed letter to both Iowa and Minnesota providing data comparing Medica’s tiering and coverage with that of other issuers the two Marketplaces, showing that Medica was an extreme outlier among issuers in both states.
IID responded to the follow-up data, seeming to concur with our assessment and indicating that the Department would require Medica to offer improved coverage and tiering of antiretrovirals in the 2026 plan year. Once those formularies became public in late 2025, we found that despite significant improvements in both coverage and tiering, Medica remained an extreme outlier on the Iowa Exchange, prompting us to write a third letter to IID, as shown in the data presented earlier (page 6-7 of this comment).
IID responded in detail to our follow-up letter, noting that Iowa does not have specific laws or regulations regarding QHP formularies, and that therefore IID follows CMS regulations and guidance. According to IID, Medica’s formulary passed the CMS Non‑Discrimination Clinical Appropriateness Review tool with no deficiencies in HIV drug coverage. Regarding adverse tiering, IID reiterated that after requiring Medica to change its formulary, the Adverse Tiering tool showed that no more than half of the drugs to treat HIV were placed on the highest cost‑sharing tier—a standard the Division determined to be compliant with CMS requirements.
We have never received a formal response from Minnesota’s insurance regulator.
Though we have not submitted formal complaints, Medica continues to offer similar discriminatory and substandard formularies in other states, such as Kansas, Missouri, Nebraska, North Dakota, Oklahoma, and Wisconsin.
- Community Health Choice Texas
In September 2023, we filed a complaint with CCIIO, which performs QHP review and enforces ACA market reform provisions in Texas, regarding Community Health Choice’s “Premier” and “Select” plans.[16] In our complaint, and in a subsequent follow-up letter,[17] we detailed the severely restricted access to HIV medications in the formularies, with “Select” plans only covering three out of twelve STRs and only offering severely restricted coverage to first-line regimens and to products containing tenofovir alafenamide, which offer benefits to people with kidney function or bone density concerns. Many covered drugs consisted of rarely-prescribed, outdated generic formulations.
In March 2024, following media attention and advocacy, Community Health Choice improved drug tiering. Our analysis showed that in 2024, 48% of antiretrovirals were placed on the highest-cost tier; by 2026, that figure had dropped to 26% for one plan and 10% for the other. However, the plans remained discriminatory due to continued failure to cover recommended single-tablet regimens and tenofovir alafenamide based therapies.
We have reviewed the 2026 Community Health Choice formularies. On tiering, the plans have made substantial improvements, with far fewer antiretrovirals placed on the highest-cost tier. On coverage of guideline-recommended treatments, however, no substantial changes have been made; the plans continue to omit coverage of all but a handful of single-tablet regimens:
Notably, even though the CMS’s Non-Discriminatory Clinical Appropriateness Tool now requires, for plan year 2026, coverage of at least two out of six first-line single-tablet regimens, the CHC of Texas “Select” plans do not cover any. In its review, CMS determined that the plans “appear to offer sufficient coverage,” and acknowledged that while one plan places all single-tablet regimens on the highest tier, another plan places at least one such regimen on a lower tier.[18] Yet the standard for discrimination under federal law is that a plan discriminates if all or a majority of drugs to treat a condition are placed on the highest tier. By that measure, these plans remain noncompliant.
Because CMS performs QHP review functions in Texas, the agency is allowing plans to fall short of even the inadequate standard of covering two out of six first-line single-tablet regimens. Not only do the agency’s formulary review tools require significant updating, it would appear that plans that fail to meet even these very limited standards continue to be offered and there is insufficient enforcement.
Substandard and discriminatory formularies that deter enrollment by people with HIV should never pass QHP review and be offered on the Marketplace. It should not take time-intensive formal complaints (and media coverage) to stop issuers from discriminating against people with HIV, who require lifelong access to complex combination regimens that are the result of decades of scientific progress.
In conclusion, we urge CMS to prioritize oversight of the Marketplace, which serves as an essential safety net within the country’s health insurance system and is of critical importance to people affected by HIV and other serious and chronic health conditions. We urge the agency to:
- Reject proposals that decrease access to care by weakening network adequacy, time and distance, and ECP standards
- Enforce existing rules requiring copay assistance to count towards patient cost-sharing and that covered drugs are considered EHB
- Improve the tools CMS provides to regulators to detect formulary coverage that deters enrollment by people living with HIV
As the key regulator of health insurance in the United States, we urge CCIIO to ensure that Marketplace plans provide meaningful, affordable, and non-discriminatory coverage to all.
If you have any questions, comments, or would like to discuss these issues further, please contact Carl Schmid, Executive Director, HIV+Hepatitis Policy Institute, at cschmid@hivhep.org or (202) 462-3042; or Kevin Herwig, Health Policy Manager, HIV+Hepatitis Policy Institute, at kherwig@hivhep.org or (617) 666-6634.
Sincerely,
Carl E. Schmid, II
Executive Director
cc: Jeff Wu, Deputy Director for Policy, CCIIO
[1] Highmark’s HCR Essential formulary in West Virginia, accessed on March 19, 2026 at https://client.formularynavigator.com/Search.aspx?siteCode=6571849149, designates multiple antiretroviral drugs, including 5 out of the 6 single-tablet regimens recommended as first-line therapy, as falling under its Copay Armor maximizer program.
[2] 45 CFR 156.122(a)(3)(iii)(H); 45 CFR 156.225(b)
[3] 45 CFR 156.125(a)
[4] Available at https://www.qhpcertification.cms.gov/QHP/applicationmaterials/Review-Tools
[5] Tables 6a and 6b, https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/tables-adult-adolescent-arv.pdf
[6] https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/what-start-nucleoside-reverse-transcriptase-inhibitor
[7] https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/optimizing-antiretroviral-therapy
[8] https://www.cms.gov/marketplace/resources/data/essential-health-benefits#Hawaii
[9] https://www.cms.gov/marketplace/resources/data/essential-health-benefits#Illinois
[10] https://www.cms.gov/marketplace/resources/data/essential-health-benefits#Idaho
[11] CMS should be commended for updating requirements to include the two oral PrEP drugs, an important reflection of rapidly evolving innovations in HIV prevention. We urge CMS to consider adding all FDA-approved PrEP drugs, which are, for example, required to be covered as a preventive service under Medicare Part B.
[12] See, for example, the 2016 Payment Notice Final Rule (80 FR 10822): https://www.federalregister.gov/documents/2015/02/27/2015-03751/patient-protection-and-affordable-care-act-hhs-notice-of-benefit-and-payment-parameters-for-2016
[13] For example, Medica with CHI Health Gold $0 Copay PCP Visits + Adult Eye Exam, Medica Insure Silver $0 Copay PCP Visits, and Elevate by Medica Bronze Share.
[14] For example, Oscar Bronze Classic 4700 or Wellmark Bronze Traditional HMO.
[15] https://hivhep.org/wp-content/uploads/2024/12/Press-Release-on-HPHC-Formulary-Changes-12.16.24.pdf
[16] https://hivhep.org/wp-content/uploads/2023/09/HIVHep-tx-community-health-choice-complaint-Sept-2023-FINAL.pdf
[17] https://hivhep.org/wp-content/uploads/2024/10/Community-Health-Choice-ACA-non-compliance-for-HIV-Rx-10.7.24.pdf
[18] https://hivhep.org/wp-content/uploads/2024/01/HIVHep-Community-Health-Choice-FINAL.pdf