Comments on 2027 Notice of Benefits and Payment Parameters proposed rule

August 13, 2026

Dr. Mehmet Oz
Administrator
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Administrator Oz:

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 Notice of Benefits and Payment Parameters for 2027 Proposed Rule (the proposed rule).

We will also be commenting on the 2027 Draft Letter to Issuers. In those comments, we will note that while the Center for Consumer Information and Insurance Oversight (CCIIO) claims it will continue to enforce several patient protections included in federal law, including those related to non-discrimination, we are profoundly disappointed that, in practice, neither CCIIO nor state regulators are upholding these standards. Specifically, we will highlight ongoing failures to enforce prohibitions on adverse tiering in drug formularies and requirements to cover drugs included in widely accepted treatment guidelines. To illustrate the impact, we will outline a number of recent examples of formularies that CCIIO and state insurance regulators continue to allow issuers to offer that discriminate against people living with HIV by using benefit designs that discourage their enrollment.

While we appreciate the intent to make healthcare more accessible and affordable, we believe that many of the policies in the proposed rule will actually make Marketplace plans less accessible and increase patient costs. Additionally, we express our extreme disappointment that CMS and other federal agencies failed to take long-promised steps to make prescription drugs more affordable for patients.

The comments below address:

Proposed actions that jeopardize insurance access and affordability
Failure to update the definition of “Cost-sharing” to include copay assistance
Failure to define all covered drugs as “Essential Health Benefits” in large group and self-funded plans
Failure to address “Alternative Funding Plans”

1) Proposed Actions that Jeopardize Insurance Access & Affordability
Several policy changes included in the proposed rule will negatively impact patient access to health coverage and affordability of care. This includes eliminating standardized health plans; relaxing requirements that expand catastrophic plans; loosening standards for provider networks and essential community providers; and removing state flexibilities on essential health benefits.

While the intent of each of these proposals is to lower overall health costs, they all will result in reduced access and increased costs for beneficiaries. We strongly urge you to not move forward with these proposals.

2) Copay Assistance & Definition of Cost-sharing
Two and half years ago, on September 29, 2023, the United States District Court for D.C. in HIV and Hepatitis Policy Institute et al. v. HHS et al. struck down the section of the 2021 Notice of Benefits and Payment Parameters rule that allowed issuers to decide if copay assistance can count or not (see Attachment 1). At the government’s request, that same Court clarified that the 2020 Notice of Benefits and Payment Parameters rule is now in effect (see Attachment 2). That means that issuers must count copay assistance in most instances and not implement copay accumulators.

The rule states:

“Notwithstanding any other provision of this section, and to the extent consistent with state law, amounts paid toward cost sharing using any form of direct support offered by drug manufacturers to enrollees to reduce or eliminate immediate out-of-pocket costs for specific prescription brand drugs that have an available and medically appropriate generic equivalent are not required to be counted toward the annual limitation on cost sharing (as defined in paragraph (a) of this section).” 45 C.F.R. § 156.130(h)(1)

As HHS explained when adopting the rule: “Where there is no generic equivalent available or medically appropriate,” manufacturer assistance “must be counted toward the annual limitation on cost sharing” (84 Fed. Reg. at 17,545).

Instead of complying with the Court’s ruling and issuing guidance to insurers of their legal obligations, CMS has ignored it, stating that it would issue a new rule regarding cost-sharing. However, two and a half years later, that rule has yet to be proposed. Much to the disappointment of the patient community, the current proposed rule does not even mention the issue or next steps. At least in the previous Draft NBPP Rule, CMS wrote:

“HHS and the Departments of Labor and Treasury intend to issue a future notice of proposed rulemaking [to] address the issues arising out of HIV and Hepatitis Policy Institute et al. v. U.S. Department of Health and Human Services et al., Civil Action No. 22-2604 (D.D.C. Sept. 29, 2023), namely, the applicability of drug manufacturer support to the annual limitation on cost sharing.”

That statement was made on October 4, 2024, more than two years ago. Every day that this rule is delayed, patients are forced to pay more for their prescription drugs while insurers and Pharmacy Benefit Managers (PBMs) continue to pocket billions of dollars meant for patients who are struggling to afford their medications. This stands in stark contrast to President Trump’s repeated statements and desire to make prescription drugs more affordable to patients.

Not only does this inaction increase the cost patients must pay for their drugs, it creates confusion in the states and instability in the prescription drug market.

While a new rule is not strictly necessary, if one were to be issued, it must require copay assistance to count as cost-sharing. Given that the federal government sided against patients and defended insurers and PBMs in our litigation, we are very concerned about which direction a proposed rule might take. We cannot imagine how the government can decide differently. The Court concluded what patient groups have long maintained: copay accumulators increase patient costs, increase drug manufacturer payments, increase insurer revenues, and are not drug discounts.

Counting cost-sharing towards the out-of-pocket (OOP) maximum is consistent with Congressional intent of the Affordable Care Act (ACA) and is consistent with the plain language of the statute itself.

Title 42 USC Section 18022 both establishes the out-of-pocket maximum and defines the “cost sharing” that must be counted towards it. That section of the ACA unambiguously provides that the “cost sharing” required to be recognized includes “deductibles, coinsurance, copayments, or similar charges.”

The plain language meaning of the statute is clear, with no carve-out to its broad applicability. The source of the funds used to satisfy these amounts is irrelevant to the statutory mandate that they must be counted. Any such “charge” to a patient, regardless of the source of the funds used to satisfy that “charge,” must be recognized for purposes of the OOP maximum. It does not matter if the source of the funds used to satisfy any of those “charges” is a parent, a sibling, a family friend, a charity, or a drug manufacturer sponsoring a copayment card. The statutory text, along with the structure and purpose of the statute, speak directly and decisively to the question. They must be counted.

We urge the federal government to uphold the Court’s decision, and, if a new rule is proposed, it must ensure that copay assistance counts as cost-sharing, as it is the only reading of the term “cost sharing” that CMS can lawfully adopt.

Patient Stories
The HIV+Hepatitis Policy Institute receives countless stories from patients and their families who have been harmed by copay accumulator and maximizer programs forced upon them, usually without their knowledge, by insurers, PBMs, or employer benefit administrators. Many contact us after reading press coverage of our Court victory and wonder why the copay assistance they have received is still not being counted as cost-sharing, and why they have to come up with thousands of additional dollars to pay for their prescriptions. These people are confused, frustrated, and fearful, wondering why the government is not enforcing the Court’s decision, and want to know what they can do and are willing to hire lawyers to help them out.

Below are just some of these real-life patient experiences we have received this year illustrating the severe and ongoing harms caused by the federal government’s failure to enforce the Court’s ruling and stop the expansion of accumulator and maximizer schemes.

North Carolina Patient with Eczema
A patient relying on a high-cost medication reported CVS Caremark did not apply a copay card valued at $10,000… to the deductible,” and that they “had no clue they were doing that.” When they contacted the North Carolina Department of Insurance, they were told that because CVS is headquartered out of state, “they didn’t have to apply” the assistance—even though the patient’s previous insurer had.

Patient with Crohn’s Disease and a Connective Tissue Disorder
This patient requires a specialty medication. Their employer insists it “doesn’t have to follow the federal law as determined by the 2020 NBPP and the 2023 federal court ruling, they’re also saying” that the plan is “not an insurance company” to try to justify not having to apply copay assistance towards the deductible or out-of-pocket maximum. “This really stinks because I would have used the rebate program the manufacturer offers if I knew they were going to do this.” Appeals and letters from lawyers have been dismissed even though the state has enacted a ban on copay accumulator programs.

Parent of a 9-year-old Child Using Dupixent
A parent whose daughter depends on Dupixent notes that the manufacturer provides $10,000 annually in copay assistance, but that their employer’s self-funded HDHP excludes that assistance using an accumulator. Their employer’s HR department informed them that an HSA-compatible HDHP “is not legally permitted to count drug manufacturer support towards the plan’s deductible.” The parent, who followed the litigation closely, asks whether the ruling protected their daughter and why their employer is allowed to disregard it.

Alabama Husband of Patient with Stiff Person Syndrome and Lung Cancer
The patient, who receives intravenous immunoglobulin treatment and recently underwent surgery for lung cancer, obtained copay assistance from a foundation in 2024, but Blue Cross Blue Shield of Alabama nevertheless “failed to credit the payment to her deductible.” Her husband, an attorney, wrote that Judge Bates’s decisions “clearly establish[es] co-pay accumulator programs are illegal” and is preparing litigation.

Illinois Patient Living with HIV
A patient stable on Biktarvy since 2019 discovered to their surprise that their new Cigna employer-sponsored plan had implemented a copay accumulator without any notice. They explained that the new benefit design “really just delay[s] payment of the entire out-of-pocket maximum” resulting in a $4,500 annual cost to them. They added that “copay accumulator programs are federally banned, and … banned in the state of Illinois,” and asked, “is this legal? Anything I could/should do?”

Texas Patient Seeking Legal Action
A Texas patient covered by an employer plan administered by BCBS of Tennessee and CVS Caremark reported that CVS’s “True Accumulations” program blocks all copay assistance from counting, leading them to pay over $10,000 in cost-sharing in 2024 alone. They report receiving “materially false summaries” of their plan’s terms and being unable to obtain documentation required under ERISA. They wrote, “I would be an ideal plaintiff to continue the legal fight,” and are exploring litigation against both the employer and the PBM.

California Crohn’s Disease Patient Forced to Enroll in Copay Maximizer Program
This patient has lived with Crohn’s for two decades and is a licensed pharmacist. Though their employer’s plan lists a $50 copay for specialty drugs, CVS Caremark requires 30% coinsurance or about $3,000 a month for the two specialty medications they rely on, Rinvoq and Hyrimoz, after they declined to enroll in PrudentRx, CVS Caremark’s vendor for copay maximizer programs. The patient notes that this amount “exceed[s] both the listed copay price and both individual and family out of pocket maximums.” CVS confirmed that these payments “would not accrue towards deductibles or out-of-pocket limits, because the medications were classified as “non-essential health benefits.” They were told this designation could not be appealed. The patient wrote, “I feel I have exhausted all reasonable options… I’m concerned their practices are resulting in financial damages and barriers to care.

These patient reports—from multiple states, plan types, and health conditions—illustrate the systemic, ongoing harm caused by CMS’s failure to enforce the law.

Patient Scenarios: Copay Accumulators and Maximizers
The payer community has perpetuated some confusion about the impact of copay accumulators and maximizers on patients, drug manufacturers, and payers. Payers have repeatedly contended, even in court, that they do not collect the copay assistance and are not double-billing or collecting more than they should under the ACA. While they are correct that the pharmacy, not the payer, collects the copay assistance, it does delay when insurers have to pick up the costs of the drugs. Payers clearly benefit from the copay assistance first collected from the drug manufacturer and then, since it did not count as cost-sharing, the additional out-of-pocket costs from the patient. In 2024, the amount they collected in copay assistance attributable to accumulators and maximizers was $7 billion.[1]

If payers did not benefit financially from these programs, why would they implement copay accumulator programs? Why do they defend them and work so hard to make sure the copay assistance does not count? It is clear they are doing this to decrease their costs and increase their revenues and profits, all at a great expense to patients. We are extremely disappointed that the federal agencies continue to side with insurers and PBMs to the detriment of patients who depend on copay assistance to afford their medications.

As the patient scenarios below clearly illustrate, individuals in copay accumulator plans pay much more in cost-sharing than they would if their assistance counted. Furthermore, in both accumulators and maximizer schemes, payers collect far more revenue than intended under the ACA when copay assistance counts.

Confirm Insurers are Including Copay Assistance in Medical Loss Ratio
Pursuant to Section 2718 of the Public Health Service Act, the ACA generally limits the total percentage that many plans may take in either profits or administrative costs to 15 or 20 percent of the claims incurred. Importantly, as of late 2025, about four in ten commercially insured lives were enrolled in plans using a copay accumulator or a maximizer.[2] This indicates that plans and/or their PBMs are capturing literally billions of dollars in additional funds each year.

Under Section 2718, plans are obliged to apply these amounts against incurred losses and claims, which, in turn, reduces the amount that can be taken as profits or for administrative costs under the applicable caps. If accounting for these billions triggers a cap, rebates must be generated.

Insurers are also required, under Section 2718 of the Public Health Service Act, to annually submit a Medical Loss Ratio (MLR) report to CMS. If a plan has not appropriately accounted for accumulator and maximizer revenues, their MLR report to CMS would be false, creating potential civil and even criminal liability.

Significantly, concern has been voiced that, separate from this issue, plans may “manage” their reporting to retain profits in a manner that is either inconsistent with the letter or the spirit of the MLR cap.[3]

We request that CMS confirm that these laws are properly being implemented, ensure proper oversight of insurers, and take appropriate action against plans that are not in compliance.

Proliferation of Copay Accumulators & Copay Maximizers
The use of copay accumulators and copay maximizer programs continues to increase due to the federal government’s inaction in issuing rules to stop them and their lack of enforcement following our favorable Court decision.

As illustrated in the graph below, in 2020, 27 percent of commercial plans had implemented copay accumulators, which increased to 39 percent in 2025. For copay maximizers, 39 percent of commercial plans had implemented copay maximizers in 2025, compared to 24 percent in 2020. The percentage of plans that include them but not yet implementing them is much higher.

According to IQVIA, copay accumulator and maximizer programs accounted for $7 billion of copay assistance in 2024.[4]

Increased Out-of-Pocket Expenses for Patients & Their Impact
There is no doubt that patients need copay assistance to afford their prescription drugs, particularly given high deductibles and cost-sharing, often expressed in terms of coinsurance, or a percentage of the list price of a drug.

While much attention is focused on list prices, patient out-of-pocket costs—the amount of money people actually pay for their drugs—are set by the insurers. Due to insurance benefit design, as described below, issuers are forcing beneficiaries to pay high costs, especially when compared to other healthcare services.

According to CMS’ 2024 National Health Expenditures report, illustrated below, patients paid only 2.5 percent of hospital care spending out-of-pocket, despite hospital care accounting for nearly four times more total spending than prescription drugs. Despite the much smaller total amount of spending for prescription drugs, the out-of-pocket spending for prescription drugs ($55 billion) was higher than all the out-of-pocket spending for hospitals ($40.6 billion).[5]

CMS has already announced that the maximum annual out-of-pocket cost will be increasing in 2027 by 13 percent from 2026. For 2027, it will be $12,000 for an individual and $24,000 for a family. The 2026 limits are $10,600 and $21,200, respectively. This is a great deal of money, which most people do not have, and it is on top of the cost of monthly premiums.

Due to the proliferation of high-deductible plans, depending on the drug, an individual may be required to pay the total amount of $12,000 all at once for their medication at the beginning of the year.

According to KFF, the 2026 silver plan average deductible is $5,304 (compared to $4,902 in 2025) while the bronze plan average deductible is $7,476 (compared to $7,186 in 2025).[6]

That is why patients who use prescription medications rely on copay assistance. As illustrated in the graph below, according to IQVIA, in 2024 patient out-of-pocket costs for medicines was $98 billion. That was an increase of $6 billion from 2023.

Due in part to high patient out-of-pocket costs, patients do not always pick up their prescription drugs. As detailed below, according to an IQVIA analysis, an estimated 96 million prescriptions were abandoned at the pharmacy in 2024, with an abandonment rate of one in four for prescriptions with out-of-pocket costs above $75.[7] For prescriptions with a final out-of-pocket cost above $250, 54 percent are not picked up by patients, as compared with 7 percent of patients who do not fill when the cost to them is less than $10.In order to afford their prescription medications, patients and families rely on copay assistance. In 2024, manufacturer copay assistance brought down patient costs by nearly $21.5 billion and accounted for 25 percent of out-of-pocket costs.[8] Over the last five years, copay assistance accounted for $91 billion. Without copay assistance, the American people would have had to come up with all this money, which most people do not have.

Consider some recent surveys regarding patient affordability of prescription drugs:

A June 2025, GoodRx survey titled “More Americans Than Ever Are Struggling to Afford Their Prescription Medications” found the following:
- 67% of Americans who filled a prescription described the cost of their medication as a burden.
- Paying for prescription drugs leads many Americans to make sacrifices in other areas of life. Almost 30% of people reported cutting back on spending for food or clothing to pay for their prescriptions.
- 38% of people said they worried about being able to afford their medications, up significantly from 27% in 2024.
- High out-of-pocket costs change how people take their medications. Among people who filled a prescription in 2025, 1 in 5 reported rationing their medications due to cost.

A KFF survey released in January 2026 titled “Americans’ Challenges with Health Care Costs” found the following:
- About one in five adults (21%) say they have not filled a prescription because of the cost, while a similar share (23%) say they have instead opted for over-the-counter alternatives.
- About one in seven adults say they have cut pills in half or skipped doses of medicine in the last year because of the cost.
- A third of all adults say they have taken at least one of these cost saving measures in the past year, including larger shares of women and those with lower incomes.

Copay Accumulator State Bans Lead to Lower Patient Costs & Greater Adherence
A study released in 2024 and was included in our comments on the 2026 Proposed Rule (see Attachment 3) conducted by Oxford PharmaGenesis examined the impact of copay accumulator adjustment program (CAAP) bans in five states (Arizona, Georgia, Illinois, Virginia, and West Virginia) and patient cost and adherence of autoimmune or multiple sclerosis drugs between January 1, 2017 to December 31, 2021.[9] The study found:

States that implemented a CAAP ban had relative reductions in patient liability after the first two months, which ranged from 41% to 63%, with monthly savings ranging from $128 to $520.
Patients in states with a CAAP ban had 14% greater odds of being adherent to their treatment after policy implementation than patients in states without a CAAP ban and a 13% reduction in risk of discontinuing.

Looking at patient liability:

In states without a CAAP ban, patient liability increased from a range of $930 (January) to $88 (November) before the policy effective date to a range of $930 (January) to $103 (November) after the policy effective date.
In contrast, in the states that implemented a CAAP ban, the mean monthly patient liability reduced from a range of $2,781 (January) to $303 (November) before the policy effective date to a range of $2,460 (January) to $164 (November) after the policy effective date.
For states with a CAAP ban, relative reductions in patient liability were similar to those of states without a CAAP ban in January and February, whereas relative reductions were greater from March through December, ranging from 41% to 63% and monthly savings ranging from $128 to $520.

A more recent study released in October 2025 titled, “Balancing Patient Affordability and Insurer Costs: Evidence from State-Level Copay Accumulator Bans” (See Attachment 4) conducted by researchers at Penn State and the University of Toronto examined the impact of state copay accumulator bans between 2018 and 2020. They concluded:

“First, we find that the ban raises the annual purchase quantity per patient by 40.0% (e0.337 – 1), indicating support for H1. That is, the ban allows the average patient to fill more prescriptions over the year, possibly suggesting improved adherence to prescribed treatment. In addition, the ban lowers the average patient OOP spending per quantity by 18.2% while raising the average insurer spending per quantity by 15.6%, indicating support for H2 and H4. These results suggest the improvement in affordability is achieved by shifting the average patient’s financial responsibility to the insurer, which in turn allows the patient to fill more prescriptions (i.e., possibly improve adherence). Meanwhile, contrary to expectations, the ban is not found to increase the overall patient volume on copay-assisted medications, indicating rejection of H3. That is, the results possibly suggest unimproved access in the post-ban years, despite the ban’s financial advantages revealed at the patient-level.”

Confusion in the States
While the federal government is allowing insurers and PBMs to implement copay accumulators, 26 states, Puerto Rico, and DC have enacted legislative bans on them in state regulated plans. Two additional states, Nevada and Minnesota, rightly require plans to abide by the federal Court decision. According to Avalere Health, their analysis of AIS Health Data’s September 2025 enrollment data found that at least 17 percent of the total US commercial market (approximately 34.28 million individuals) are enrolled in plans that must count any form of copay assistance toward patient cost-sharing limits.[10] This patchwork is creating great confusion throughout the country for patients, regulators, payers, and drug manufacturers and is another reason why the federal government should issue a rule requiring copay assistance to count.

Copay Assistance Does Not Increase Premiums
Proponents of copay accumulators frequently argue that copay assistance leads to higher premiums. However, research conducted by The AIDS Institute reveals that there is no difference in premiums between plans that have instituted copay accumulators and those without them in the states that have not yet banned copay accumulators.[11] See graphic below.

3) Covered Drugs Must be Included as Essential Health Benefits
We were pleased that CMS codified in the 2025 Notice of Payment and Parameters Rule the policy that prescription drugs covered in excess of the state’s benchmark plan are to be considered essential health benefits (EHB) in the small group and individual markets, and therefore, are subject to EHB protections, including annual cost-sharing limits. However, it did not make the same clarification for the large group and self-funded markets, though it said it would do so in the future.

Unfortunately, the 2027 Proposed Rule failed to include this important clarification. We urge the federal agencies to issue a rule that applies this same principle to all plans to close this loophole.

Due to the federal government’s inaction, payers and vendors using this scheme continue to implement copay maximizers by exploiting copay assistance from drug manufacturers far in excess of ACA out-of-pocket maximums.

In our comments on the proposed 2025 Notice of Benefits and Payment Parameters Rule, we described how certain entities are working with employers and insurers to implement schemes that designate certain prescription drugs as “non-essential health benefits.” The drugs selected just happen to be the ones whose manufacturers offer copay assistance. The copay assistance does not accumulate toward the beneficiaries’ deductible or out-of-pocket maximum and the vendors then exhaust all of the available copay assistance for themselves and split it with the payers. To accomplish this, they force the beneficiaries to sign up for copay assistance programs but if they do not, require them to pay a high cost, such as 30 percent coinsurance.

As we wrote in our comments for the last two years, it is rather ironic that while there are entities (including insurers) that voice strong opposition to copay assistance, at the same time, they are working with others that are taking advantage of the copay assistance programs and extracting as much as they can for themselves.

To make matters worse, the federal government is allowing these schemes to continue and grow.

While stopping the use of “non-EHB” schemes will end the practice of copay maximizers, doing so without also requiring copay assistance to count will likely simply enable payers to convert copay benefit designs into copay accumulator benefit designs. As described in the patient scenarios above, accumulators have a much greater financial impact on patients. Therefore, it is necessary for the federal government to end the “non-EHB” loophole and make copay assistance count.

4) Alternative Funding Programs (AFPs)
In addition to entities that designate “non-EHB drugs” in order to extract manufacturer copay assistance to implement a copay maximizer, there are other vendors that also use “non-EHB drug” designations to implement alternative funding programs. In these programs, patients who use certain medications are directed to enroll in an alternative program (which is not insurance) in order to bypass ACA laws and regulations relative to patient cost-sharing limits and other patient protections. They then find alternative funding mechanisms, such as imported drugs or patient assistance programs, to supply the drugs to the patient. If the patient does not comply, they will be left paying the full cost of the drug.

In our comments on the 2025 proposed rule, we described in more detail some of these companies and how they work. We described that for as an alternative funding source, one vendor uses “manufacturer free programs, grants/charities, our International Mail Order Pharmacy partner, domestic wholesale pharmacy and occasionally a copay card.” Another vendor forces patients to sign up for drug manufacturers patient assistance programs, which are free drug programs meant for people who are uninsured.

There are a growing number of other vendors that are working with insurers, employers, and PBMs around the country.

The federal government must investigate and prohibit these harmful schemes.

We thank you for the opportunity to share these comments and look forward to working with you as you seek to make healthcare, particularly prescription drugs, more affordable and accessible for more Americans. 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