Comments on 2026 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, D.C. 20201
Dear Dr. Montz:
The HIV+Hepatitis Policy Institute, a leading national HIV and hepatitis policy organization promoting quality and affordable healthcare for people living with or at risk of HIV, hepatitis, and other serious and chronic health conditions, is pleased to offer comments on the 2026 Draft Letter to Issuers (2026 Draft Letter). We will be submitting separate comments on the Notice of Benefits and Payment Parameters for 2026 Proposed Rule.
Sadly, due to the lack of positive steps taken by CMS in the enforcement of the ACA and its own requirements, our comments are very similar to those we submitted on the 2025 Draft Letter to Issuers. We urge you to take the necessary steps to protect patients against insurer violations of the ACA, including the all-important non-discrimination provisions. Without proper enforcement, it will be more difficult for beneficiaries to access and afford the healthcare that they need.
Issuers Must Count Copay Assistance
While we will be discussing this issue in more detail in our comments on the 2026 Notice of Benefits and Payment Parameters proposed rule, we urge CMS to add to the 2026 Final Letter a reminder to issuers that copay assistance for prescription drugs must be counted for all but brand name drugs with a generic equivalent.
It has been over a year since the District Court for D.C. struck down in HIV and Hepatitis Policy Institute et al. v. HHS et al. the section of the 2021 Notice of Benefits and Payment Parameters rule that allowed issuers to decide if copay assistance can count towards out-of-pocket obligations or not, and that same Court clarified, at the government’s request, that the 2020 Notice of Benefits and Payment Parameters rule is now in effect. Issuers must count copay assistance in most instances and not implement copay accumulators.
While CMS continues to indicate that it will issue a new rule, to date it has not done so. Therefore, in the meantime, it must remind plans that the 2020 NBPP rule is now in effect and must be followed. Plans are continuing to institute copay accumulator benefit designs that harm patients and increase their prescription drug costs. On top of this, while CMS allows insurers to flout the law, almost all plans are not transparent and do not make it clear to their beneficiaries that any copay assistance they receive will not count toward their out-of-pocket obligations.
CMS is Further Backsliding on Adverse Tiering & Discriminatory Plan Benefit Reviews
We are pleased that CMS has once more reiterated to payers that they must comply with the essential health benefits non-discrimination requirements that were first included in the 2017 Letter to Issuers. These requirements state that placing “all or a majority of drugs needed to treat certain chronic medical conditions” on high cost-sharing tiers “might effectively discriminate against, or discourage enrollment.”
However, CMS appears to be backtracking on this essential regulation. In the 2025 Draft Letter CMS incorrectly wrote that the final 2023 Payment Notice “established adverse tiering as a presumptively discriminatory practice when placing all drugs for particular high-cost chronic condition(s) on the highest formulary tier, even when those drugs are costly.” In our comments on the Draft Letter we pointed out this error and the need to add the words “or a majority of” drugs. Instead of correcting it, CMS merely deleted it from the Final Letter.
While this rule is still in effect and plans must follow it, we strongly believe they should be reminded of this requirement and question why it was not corrected and instead, was ultimately removed from the final 2025 Letter. We trust CMS will still be upholding this important nondiscrimination patient protection regulation.
On top of it, similar to the last three years, CMS states it will conduct adverse plan reviews of drugs that are used for the treatment of four health conditions: HIV, hepatitis C, multiple sclerosis, and rheumatoid arthritis.
The 2026 Draft Letter states (as did the 2025 Letter) plans will only be “flagged for possible adverse tiering if all drugs for at least one of the four medical conditions are placed on the highest effective cost-sharing tier.” The consistent removal of the words “or a majority of” drugs for two years in a row is obviously no accident and we strongly urge CMS to uphold its adverse tiering rule by conducting their reviews to flag plans when all or a majority of drugs to treat a certain condition are on the highest cost tiers.
To make matters worse, CMS has indicated it would conduct these adverse tiering reviews of the drugs used to treat the same four conditions since the 2024 Letter to Issuers and we have not seen any results. We would be interested in learning if these reviews occurred and what action CMS has taken against insurers to enforce these longstanding prescription drug coverage regulations. Since we continue to find plans that violate these regulations (see below), we doubt the reviews have occurred, which allows plans to continue to violate the law and, in the process, harm patients.
While the 2026 Draft Letter states that “to ensure robust consumer protection against potentially discriminatory benefit designs, CMS will continue to review plan benefit designs to ensure they are nondiscriminatory and align with 45 CFR 156.125,” CMS again deemphasizes what this requirement entails. In the 2024 Letter to Issuers CMS stated, “The adverse tiering review will check that QHPs cover sufficient drugs or drug classes prescribed to treat chronic, and high-cost medical conditions at lower cost tiers.” However, that statement was dropped in the 2025 Letter and CMS instead used a footnote to the rule. In the 2026 Draft Letter, while the rule is mentioned, there is no footnote to the rule nor any mention of the drug coverage requirements or the need to follow clinical treatment guidelines.
We urge CMS to reiterate in the final 2026 Letter that the prescription drug reviews include the adequacy of the drugs on the formulary to treat specific conditions in accordance with broadly accepted treatment guidelines, and that the reviews must be clinically based, as required by ACA essential health benefit regulations.
This is particularly important since we continue to find plans that do not comply with these requirements (see below) and CMS continues not to enforce its own regulations.
CMS and Not All States Enforcing Existing Regulations
Sadly, we continue to find plans that violate the patient protection regulations and remain extremely disappointed by the lack of enforcement.
It has been clear policy since 2016 that it is discriminatory to design formularies which place a majority of drugs to treat a specific condition on the highest tiers. And yet, CMS does not appear to enforce this, instead relying on consumer complaints to identify insurers who violate these important patient protections contained in the ACA. Instead of relying on consumers and patient groups to identify violations, CMS and state regulators should be conducting proactive reviews of plans as part of the plan approval process.
Since many state regulators do not seem to have sufficient resources or staff to have an adequate understanding of HIV treatment and prevention medications, they rely on CCIIO’s templates and plan review tools to conduct these reviews. Some of them are doing an excellent job of ensuring that plan formularies include the necessary treatments in accordance with treatment guidelines, and not instituting excessive prior authorizations nor engaging in adverse tiering. Other states, including those reviewed by CCIIO, are allowing insurers to violate the law. [Note: HIV treatment guidelines have recently been updated. Therefore, CCIIO and state templates must be updated to mirror the new HIV treatment guidelines.]
On top of that, CCIIO and some states merely ask the issuers to correct a violation once it is identified. These repeated violations have real impacts on patient access and medication affordability. This is not proper enforcement. CMS appears to be relying solely on consumer complaints. Then CMS politely points out the violation to the insurer and asks them to correct it. Additionally, it seems that insurers are able to come up with excuses on why they are not violating the law and convince regulators that they are in compliance. Even in the 2026 Draft Letter, it states that CMS will merely “flag” for violations when CMS has already made clear that it is presumptive discrimination for putting all or the majority of drugs to treat a specific condition on the highest tier.
Insurers seem to be able to get away with what they can until they are caught. And, even when they are caught, they can continue to violate the law. This is not how patient groups expect the ACA to be implemented. We urge you to be more proactive and take decisive enforcement action against insurers that violate the law, levy appropriate penalties, and publicize the reviews and actions taken. The plan reviews for adverse tiering and compliance with all other prescription drug formulary requirements must also be for applied to all drugs to treat all medical conditions, not just those for the four conditions identified in the draft Letter to Issuers.
Recent Plan Reviews for HIV Drug Coverage & Complaints Filed
We base the above comments on recent plan reviews the HIV+Hepatitis Policy Institute conducted, complaints we have filed, and the resolution, or lack thereof, of these complaints.
North Carolina Blue Cross/Blue Shield: On December 22, 2022, the HIV+Hepatitis Policy Institute and North Carolina AIDS Action Network filed a 1557 discrimination complaint with the North Carolina Insurance Department and the HHS Office of Civil Rights (OCR), and sent copies to CCIIO. We found that the 2022 and 2023 plan year formularies employed adverse tiering by placing the vast majority of drugs used to treat and prevent HIV, including several generics, on Tiers 5 and 6. Additionally, all HIV drugs had quantity limits.
After filing the formal complaints, we received an acknowledgment from OCR, informing us that the case would be handled by its Atlanta office. We never received any acknowledgment from the State of North Carolina and only learned that they had received the complaint from local press coverage.
Every month, we would check the insurer’s website to determine if there was any change in their posted drug formulary. Finally, in August 2023, we found that the formulary had been changed, and remarkably, not a single HIV drug was left on the highest and most costly drug tiers. Instead of 48 HIV drugs, including many generics, on Tiers 5 and 6, there were now none. As part of the change, the insurer also moved 19 generic HIV drugs that were on Tiers 4, 5, and 6, to Tier 2, which is the proper tier for generics, and removed “quantity limits” that were previously imposed on all HIV medications.
As a result, depending on the plan, patients will be paying more reasonable and affordable costs.
After OCR saw our press release with this change, they did reach out to us to ask if we wanted to take any additional actions. We recommended some actions and notifications the insurer can take and recommended that a financial penalty be imposed. On February 6, 2024, we received a letter from OCR indicating they had closed the case finding no violation since the insurer had corrected the situation. OCR noted that it did not even begin its investigation until October 17, 2023, after we had already announced that the insurer made the changes to its tiering of HIV drugs and accepted the insurer’s claim that it had made the changes through its normal ongoing quarterly formulary review process (despite the fact that this adverse tiering had been going on for years).
While we never received any formal communication from the North Carolina Insurance Department, they noted in comments to the press that the insurer had taken action and corrected the situation. Again, through comments made to the press, there was no indication that the state regulator ever did anything, and we can only conclude that the action taken by the insurer was a result of the negative press coverage the insurer received regarding our complaint.
As an update, at a National Association of Insurance Commissioners meeting, the North Carolina Insurance Department staff relayed to HIV+Hep staff that there was confusion as to who would handle the case (OCR or the state) and the state did not have the knowledge or the resources to properly understand which HIV drugs should be covered–even though the complaint concerned the tiering and cost-sharing rather than the coverage of the drugs.
This is not proper enforcement of ACA patient protections. These violations continued for years and were brought to the attention of the insurer by several outside parties. It should not take filing a complaint and media coverage to correct the situation.
The adverse tiering North Carolina Blue Cross Blue Shield engaged in had real-life consequences for people living with HIV. In some plans Tiers 5 and 6 translate into 50 percent co-insurance, after a deductible of $7,000 for an individual and $14,000 for a family. Moving the drugs to lower tiers resulted in lower and more reasonable copays.
Community Health Choice Texas: On September 26, 2023, HIV+Hepatitis Policy Institute filed a complaint with CCIIO against Community Health Choice Texas for substandard and discriminatory HIV medication coverage and plan design. The complaint was filed with CCIIO because it is the entity responsible for reviewing, approving, and regulating ACA plans for the State of Texas.
In our complaint, we included a number of ACA violations that we identified in the insurer’s Premier and Select 2023 plans. [Note: These coverage violations continued in the 2024 plans and are also continued in the 2025 plans that were just released.] Both formularies that severely restrict access to antiretroviral HIV treatment medications, do not adequately cover HIV treatment regimens as specified in national treatment guidelines, including single-tablet formulations, do not meet the state’s Essential Health Benefit benchmark requirements and pad the formulary with older or even discontinued drugs that are not widely used in the treatment of HIV. Additionally, most of the covered HIV treatment drugs were on a very high-cost tier, including low-cost generic drugs, and therefore engaged in adverse tiering. These high tiers require 50 percent co-insurance. Some plans also do not designate at least one of the PrEP drugs as a preventive with zero cost sharing. [Note: New CMS FAQ requires the coverage of all three PrEP drugs without cost-sharing.]
Despite all these allegations, which were all backed up with complete data and analysis, CCIIO responded to our complaint stating that the plans “appear to offer sufficient coverage” and failed to address all of our complaints. Instead of following its own regulations, they ignored them and have given numerous passes to the insurer.
Based on our complaint and media attention, in March 2024, Community Health Choice made a number of improvements to the drug tiering violations in the Premier and Select formularies, so that the majority of HIV treatment medications are no longer on the highest cost tiers. However, their plans continue to discriminate against people living with HIV in other ways.
In our comments on the Draft 2025 Letter, we detailed all the violations of the ACA law and regulations. We then followed up with a meeting with CCIIO staff in April 2024 which brought together people living with HIV, HIV specialists, and clinicians from the Houston area to discuss the deleterious impact the plans are having on HIV treatment. We then followed up with an updated letter on October 7, 2024, detailing drug by drug the HIV treatment guidelines compared to Community Health Choice’s formularies.
It is vitally important for CCIIO to step in to ensure that Community Health Choice corrects its coverage deficiencies to bring them up to the required standards. As noted above, due to the lack of action, they are continuing to offer these substandard and discriminatory plan designs in 2025 to the detriment of people living with HIV in the Houston area. As the lead regulator of ACA plans for the State of Texas, CCIIO must take enforcement action.
Medica (Iowa and Minnesota): Medica, an issuer of QHPs on the Iowa and Minnesota Exchanges, engages in adverse tiering of HIV treatment medications. In 2024, Medica placed every single HIV treatment drug but one generic (lamivudine or Epivir) on its highest cost specialty tier, Tier 5. This means that even several low-cost generics are on the highest specialty tier. We would note that lamivudine, which is also used as a treatment for hepatitis B, cannot be used as HIV treatment by itself but only in combination with one or two other drugs – so every single enrollee living with HIV in Medica’s plans in 2024 was required to use medications from the highest-cost specialty tier.
Medica’s 2025 plans, which were recently released, have modified this discriminatory plan design slightly: a generic single-tablet regimen (efavirenz/lamivudine/tenofovir disoproxil or Symfi) is now covered on the lowest-cost tier. However, because efavirenz-based regimens are increasingly rarely prescribed due to its notorious neuropsychiatric side effect burden, most enrollees living with HIV will not be able to access their treatment regimen at low cost. In terms of beneficiary cost-sharing, placed on the specialty tier drugs can require a monthly copay of $500 (even for a Gold plan), $600, $750 or even $850 depending on the plan selected. This means that monthly out-of-pocket costs that the enrollee pays can exceed the list price of the drug.
We do not understand how through the plan review and approval processes these flagrant violations of CMS rules were not flagged. We plan on submitting complaints to the state insurance regulators so that they can immediately address these discriminatory plan designs.
Harvard Pilgrim Health Care (Maine, New Hampshire, Rhode Island): Recently released 2025 Harvard Pilgrim Health Plan Marketplace plans offered in Maine, New Hampshire, and Rhode Island provide substandard and discriminatory coverage of HIV treatments since they do not provide a number of recommended drugs in current treatment guidelines. Of the four preferred regimens recommended for most people (Biktarvy, Dovato, Symtuza, or a combination of Tivicay with either Truvada, Cimduo, or Descovy), these plans only cover Dovato or Tivicay + Truvada. Of the four alternative regimens recommended in certain clinical circumstances (Delstrigo, Odefsey, Triumeq, and a combination of Prezcobix and Epzicom, only two (Odefsey and Triumeq) are covered. The insurer’s formulary used for equivalent plans in Massachusetts covers all drugs recommended among the four preferred and four alternative regimens in national treatment guidelines, showing that Harvard Pilgrim is quite able to provide non-discriminatory coverage that follows clinical recommendations.
Since most people with HIV in these three states are currently on a drug regimen that will no longer be covered, they will likely encounter treatment interruptions in the new plan year. Others will be forced to switch plans, clearly demonstrating how these substandard plans discourage enrollment by people with HIV. This is dangerous for their individual health, public health, and for communities disproportionately impacted by HIV.
We will submit complaints to state insurance regulators in the three states with the substandard formularies to urge them to bring Harvard Pilgrim Health Care into compliance by adopting formularies that follow clinical guidelines.
As the key regulator of health insurance throughout the United States and given the direct role CCIIO plays in some states, we call on CCIIO to fully review health insurance plans for benefit designs that discriminate against certain individuals, including adverse tiering and inadequate formularies. Further, we urge you to provide the states with the tools needed to ensure necessary compliance, oversight, and enforcement. And we urge CCIIO to enforce its own regulations and levy appropriate penalties.
Thank you for the opportunity to provide these comments. Should you have any questions or comments, please feel free to contact me at cschmid@hivhep.org. Thank you very much.
Sincerely,
Carl E. Schmid II
Executive Director
cc: Jeff Wu, Deputy Director for Policy