Dear Secretary Yellen, Secretary Becerra, and Administrator Brooks-LaSure:
The Cystic Fibrosis Foundation thanks the Department of Health and Human Services (“HHS” or “Department”) for the opportunity to comment on the Notice of Benefit and Payment Parameters (NBPP) for 2025 proposed rule. The Cystic Fibrosis Foundation is a national organization dedicated to curing cystic fibrosis. We invest in research and development of new CF therapies, advocate for access to care for people with CF, and fund and accredit a network of specialized CF care centers.
Cystic fibrosis is a rare, genetic disease that affects close to 40,000 children and adults in the United States. CF causes the body to produce thick, sticky mucus that clogs the lungs and digestive system, which can lead to life-threatening infections. As a complex, multi-system condition, CF requires targeted, specialized treatment and medications. If left untreated, infections and exacerbations caused by CF can result in irreversible lung damage, and the associated symptoms of CF lead to early death, usually by respiratory failure. Through careful, aggressive, and continuously improving disease management, the average life expectancy for people with cystic fibrosis has risen steadily over the last few decades. This milestone reflects over 50 years of hard work to improve CF treatments, develop evidence-based standards of care, and encourage adherence to a lifetime of chronic care. However, this system of care and the improvements in length and quality of life for those with CF can only be realized if patients have access to adequate and affordable insurance.
Thank you for the opportunity to submit comments on the Notice of Benefits and Payment Parameters for 2025 Proposed rule. The CF Foundation provides the following recommendations.
Essential Health Benefits
Standards for Essential Health Benefits (EHB) Benchmark Plan Selection
We appreciate HHS’ commitment to addressing gaps in covered benefits under the EHB standards. We support a streamlined process for states to update their benchmark plans. In recent years, only nine states have augmented their benchmark plans to address gaps in covered benefits. We believe additional states will consider updating their benchmark plans and on a more frequent basis in order to reflect the needs of the of the consumer.
However, based on the cost containment strategies that have evolved in recent years in employer-sponsored plans, we have concerns with HHS’ reliance on a typical employer plan. Self-funded, or self-insured, insurance plans are especially concerning. According to a recent Kaiser Family Foundation study, 65% of covered workers are in a plan that is self- funded and as fully insured risk pools, they are incentivized to adjust their benefits when even one enrollee has a high-cost condition. Many offer a prescription drug benefit, which is subject to Affordable Care Act’s (ACA) regulations of EHBs. Under current law, employer health plans are allowed to deem certain categories of prescription drugs as “non-essential,” even if they are necessary for people with serious, chronic conditions, like CF. When a covered drug is deemed “non-essential,” the payer will not count any cost-sharing towards the enrollee’s deductible and out-of-pocket maximum. In this system, people with CF in a “typical employer plan” could pay hundreds or thousands of dollars in out-of-pocket costs for necessary medicines and never hit their out-of-pocket maximum. Further, we are seeing some employer plans eliminate coverage of certain specialty medications altogether. Cystic fibrosis treatments rarely have lower-cost generic alternatives and, when employer plans refuse to cover specialty CF medications, people with CF face the difficult choice of foregoing these necessary treatments, changing to an often more costly insurance plan from the ACA marketplace, or in some cases making career sacrifices and seeking alternate employment.
As a result of these practices, people with CF are left with few options. In a study conducted using the Cystic Fibrosis Foundation’s case management data, people with CF enrolled in self-funded employer plan regularly experienced gaps in care, lack drug coverage, or the need to change insurance due to cost. The Foundation asks HHS to work with other agencies and Congress to establish better standards for employer coverage, including self-funded plans, and to better regulate the norms and practices of pharmaceutical manufacturers, insurers, and PBMs that put patients at risk.
Coverage of Prescription Drugs
The proposed rule clarifies that in the event a plan covers prescription drugs in excess of the minimum number covered by the state’s EHB-benchmark plan, the additional drugs are considered EHB. HHS states that this is not a policy change but rather a clarification of this longstanding rule. The CF Foundation appreciates and strongly supports this clarification, as issuers have been manipulating their drug benefit to circumvent EHB requirements in a way that creates financial and administrative burdens for people with CF.
Health plans have recently begun alleging that they are only required to cover the minimum number of drugs in the state plan, and everything in addition to the minimum number of medications in the state plan is considered a non-EHB. As described above, plans are deeming certain (often specialty) drugs to be “non-essential health benefits.” Issuers claim non-essential drugs are still considered covered by the plan, but they are not subject to the ACA EHB requirements and therefore can be removed from the ACA’s out-of-pocket maximums requirement. This practice places a significant administrative and cost burden on consumers who use high-cost, specialty prescription drugs, like people with CF.
Generally, health plans are making these changes in order to leverage maximizers or alternative funding programs. These programs artificially inflate the patient’s copay to ensure it collects all financial assistance available to the patient. This strategy has caused manufacturers to limit the amount of assistance they are willing to provide to patients or require patients to verify whether one of these programs is attached to their health plan before providing financial assistance. Many people with CF rely on third-party financial assistance to cover some of the costs associated with their care, as CF is an expensive disease. The CF Foundation recognizes that copay assistance programs mask bigger cost and affordability issues; however, cost containment strategies like accumulators, maximizers, and alternative funding programs that further burden patients are unacceptable. The Department’s clarification that all covered drugs are considered EHBs will help limit use of maximizer and alternative funding programs and help ensure access to therapies for people with CF.
As stated above, we appreciate the Department’s clarification in this proposed rule as it relates to small group and individual plans but ask HHS to work closely with other agencies to make this clarification across all insurance plans.
Copay Assistance
While we are aware of the ongoing litigation related to copay accumulator programs, the CF Foundation is disappointed HHS plans to issue a non-enforcement policy of the 2020 NBPP rule for the 2024 plan year. The lack of communication from the administration has left patients uncertain what the true out-of-pocket may be when comparing plans on the marketplace. Accumulator programs prevent third-party payments from counting towards deductibles and out-of-pocket limits and therefore increase out-of-pocket costs for patients — which can cause people with CF to forgo needed care and lead to adverse health outcomes. According to a survey conducted by George Washington University of over 1,800 people living with CF and their families, nearly half reported delaying or forgoing care — including skipping medication doses, taking less medicine than prescribed, delaying filling a prescription, or skipping a treatment altogether — due to cost concerns. Because CF is a progressive disease, patients who delay or forgo treatment face increased risk of lung exacerbations, irreversible lung damage, and costly hospitalizations.
Accumulator programs also place additional financial strain on people with CF who are already struggling to afford their care. More than 70 percent of survey respondents indicated that paying for health care has caused financial problems such as being contacted by a collection agency, filing for bankruptcy, experiencing difficulty paying for basic living expenses like rent and utilities, or taking a second job to make ends meet. And while three quarters of people received some form of financial assistance in 2019 to pay for their health care, nearly half still reported problems paying for at least one CF medication or service in that same year.
We understand the challenge insurers face in managing the rising cost of drugs, and that copay assistance programs mask bigger cost and affordability issues in the health care system. However, as mentioned above in the context of maximizers and alternative funding programs, cost containment strategies that further burden patients are unacceptable.
Accumulators are especially challenging for a disease like CF, which has no generic options for many of the condition’s vital therapies. We urge HHS to inform insurance issuers that they must immediately comply with the 2020 NBPP copay assistance provision and not issue a non-enforcement policy. HHS should further require issuers to notify enrollees of this change and advise them what to expect when they use copay assistance to meet their deductible and cost-sharing requirements.
Prescription Drug Classification
The current EHB standards governing prescription drugs require plans to cover the greater of one drug per U.S. Pharmacopeia (USP) Medicare Model Guidelines (MMG) class and category or the number of such drugs included in the state’s benchmark plan. This standard has not been updated since the EHB rules came into effect in 2014 and has proven to be inadequate for people with CF and the scientific advancements in CF care over the last 10 years. We support HHS’ proposal to transition from the USP MMG to the USP Drug Classification (DC) system. For purposes of the EHB framework and the consumers it is intended to serve, the USP DC is superior to USP MMG; the DC system includes additional drug classes needed by the broader patient population served by EHB and is updated more frequently. However, there are still improvements that could be made to the USP DC system to better reflect patients and their needs.
For instance, the USP DC classification system includes all therapies specifically indicated for CF in one category and class, even though there are different types of CF medications and formularies need to reflect those differences in order for people with CF to receive appropriate treatment. One type of therapy available for 90 percent of people with CF is CFTR modulators, which directly target defects in the processing, trafficking, and function of the CFTR protein. These therapies are distinct from other CF treatments which treat the symptoms of CF by addressing mucus clearance and bacterial infections, for example. By including all CF treatments in the same category and class, the USP DC system is not reflective of the complexities of therapies currently available on the market and in the CF development pipeline.
We recommend HHS adopt an annual process, specific to EHB regulation, that reviews the DC system to ensure it remains updated for patients’ evolving needs and to keep pace with development of new therapies. Such a review should include feedback from patients, practitioners, and evaluation of disease specific clinical guidelines.
Coverage of Adult Dental Benefits
Federal regulations prohibit an issuer from including routine non-pediatric dental services as an EHB. We support the Department’s proposal to remove this regulatory provision and hope with the updated and streamlined EHB benchmark process, states will opt to update their benchmark plan to require coverage of routine adult dental services. Continued separation of dental and oral health from general medical care exacerbates inequity and forces members of underserved communities to seek nontraumatic dental emergency care in hospital emergency departments. This trend is unnecessarily costly and results in antibiotic prescriptions and pain management. We thank HHS for moving to eliminate this unnecessary barrier to care.
Pharmacy and Therapeutics Committee Standards
The Department is proposing for 2026 plan year, the Pharmacy and Therapeutics (P&T) Committee must include a consumer representative. We support the expanded obligations for P&T Committee because the process and policy development are critical to patient access. So far, some states have taken the initiative to already have a consumer representative on their committees; however, the definitions of representative are inconsistent, and the role is often vacant. Therefore, we believe the regulations could go further than simply requiring a consumer representative. First, states should be required to reimburse consumer representative members for reasonable costs related to participating (travel, lodging, etc.) without the representative having to demonstrate need for reimbursement and consumer representatives should be compensated for their time participating in P&T Committee activities. Second, HHS should require states to allow consumer representatives to have an independent (i.e., not affiliated to the state) counsel or policy organization, to support it in any capacity the representative chooses.
Network Adequacy
As noted in our previous comments, the CF Foundation commends HHS for reexamining federal network adequacy standards for plans offered through the Federally Facilitated Marketplace (FFM) and supports the Department’s proposal in this NBPP to require all marketplace plans, in all states, to meet minimum quantitative standards of network adequacy. Establishing a federal baseline standard is consistent with how most ACA consumer protections have been implemented and allows states flexibility to regulate in ways that meet or exceed the federal minimum.
The Department decided not to require all marketplaces to adopt wait time standards at this time. Establishing wait time standards will add an important dimension to network adequacy review that is not captured by other network rules. Individuals with CF rely on access to a network of specialized providers that are critical for obtaining high-quality care. In CF, waiting too long to see a specialist could give a pulmonary exacerbation time to develop and become life threatening and timely access to providers is essential for maintaining patients’ health. We support HHS’s approach to collect data from specialists on what would be appropriate for their patient population before setting such a long wait standard.
Furthermore, as HHS considers how to improve network oversight, the CF Foundation urges the Department to scrutinize networks for their ability to provide culturally- and linguistically-competent care. This should include, among other things, a rigorous assessment of whether a network includes sufficient providers with appropriate language proficiencies, and/or provides sufficient access to appropriate language services, to ensure individuals with limited English proficiency can obtain timely care in their preferred language. It also means networks must ensure access to culturally appropriate care that reflects the diversity of enrollees’ backgrounds and is attuned to traditionally underserved communities, including people of color, immigrants, and LGBTQ individuals. Further, to enable consumers to identify the plans and providers likely to meet their needs, qualified health plans (QHPs) must be required to indicate in their provider directories the languages, other than English, which are spoken by a provider and/or their staff.
Standards for Establishing and Operating a State-Based Marketplace
Any state that wishes to assume responsibility for its own marketplace must ensure that the transition from HealthCare.gov to a state-based marketplace will further the goals of the ACA and will not make consumers worse off. Transitions that result in residents losing access to patient-friendly programs and protections that they currently benefit from through HealthCare.gov undermine the purpose of the statute. To avoid these harms, we urge HHS to extend minimum federal standards to all marketplaces and require transitioning states to be transparent about their plans and to solicit public comment during the transition process.
Marketplace transitions have significant implications for patients, consumers and other stakeholders, yet transitioning states have not been obligated to solicit public input on their transition plans or even make the public aware of such plans. This lack of transparency and public engagement heightens the risk that a state could proceed with a transition that jeopardizes its residents’ access to comprehensive coverage. We therefore wholeheartedly support the Department’s proposal to require transitioning states to publish — in a timely manner — their transition Blueprints and to engage the public during the transition process. We also support the Department’s pledge to publish these Blueprints on a federal website, and we suggest that federal publication should occur promptly, within 30 days of receipt. While the proposed rule specifies that states must provide an opportunity for interested parties to provide input, we request that the Department clarify that, for public engagement to be adequate, a state must (among other things) provide a formal notice and comment period.
Special Enrollment Periods
Existing regulations allow for a special enrollment period (SEP), available on a monthly basis, for qualified individuals with household incomes at or below 150 percent FPL. We strongly supported the adoption of this SEP, which we believe is a critical component of a broader consumer-focused strategy to reduce barriers to coverage. We understand this opportunity to be particularly significant for the target population of low-income consumers because it makes transitions from Medicaid to the marketplace — a traditionally challenging and often unsuccessful experience resulting in high levels of coverage loss — relatively easier. We support HHS’ proposal to ensure the policy continues without interruption.
As HHS evaluates potential changes and improvements to SEPs in future rule making, HHS should reconsider whether to provide an SEP to consumers whose providers leave their network mid-year. Significant network changes, whether it is initiated by the QHP issuer or the provider, can occur at any point during the year. Under Medicare Advantage, individuals affected by a significant change in their plan’s provider network are eligible for an SEP that permits re-enrollment into another plan. The CF Foundation believes that enrollees who are impacted by a provider contract termination to be someone who is experiencing an exception circumstance, and should be eligible for a new SEP. Access to an accredited CF care center is critical for obtaining medically necessary and high-quality care for people with CF. If the CF care center’s hospital or health system terminates its contract with a QHP, patients should be eligible for an SEP so they can find a plan that meets their care needs.
The CF Foundation appreciates the opportunity to provide comments on the proposed rule. We look forward to working with HHS on these critical issues to ensure access and affordability for people with CF.