Congress is considering two bipartisan bills that would help ensure people living with cystic fibrosis have affordable access to the highly specialized treatments and care they require. The Cystic Fibrosis Foundation, alongside the CF community, call on Congress to pass the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act without delay and to support the Help Ensure Lower Patient (HELP) Copays Act.
The PASTEUR Act
People with cystic fibrosis face a heightened, lifelong risk of chronic infections requiring routine use of antibiotics. The urgent need for more antimicrobial options — including antibiotics — isn't unique to the CF community; it's a universal public health crisis — with dire consequences.
Every 15 minutes, a person in the United States dies from an antibiotic-resistant infection.
Antimicrobial resistance has a substantial impact on the U.S. economy. According to a 2022 report from the National Academies of Sciences, Engineering, and Medicine, the direct medical costs in the U.S. of treating only six of the most common drug-resistant pathogens is $4.6 billion per year. Notably, this figure does not include associated and downstream costs, including the cost to the health system, lost wages, diminished worker productivity, short- and long-term disability, the cost burden on families and caregivers, and mortality.
The bill’s sponsors are pursuing a strategy that will authorize the program this Congress and allow appropriators to determine funding levels moving forward. The CF Foundation supports this approach and believes this is a critical first step to encouraging innovators to stay in this space and ensuring vital new antibiotics can enter and stay on the market.
Many patients, including those living with CF, are already running out of options and can’t afford to wait for new products to treat difficult infections. That’s why the CF Foundation is calling on Congress to act today to help ensure this necessary legislation is passed.
The HELP Copays Act
Living with a rare disease like cystic fibrosis is costly and requires expensive, specialty drugs to help manage the disease. A recent study published in the Journal of Cystic Fibrosis showed that despite near-universal health care coverage, 74% of people with cystic fibrosis surveyed utilized financial assistance or grant programs to cover or offset their health care costs.
The CF Foundation recognizes the challenges insurers face managing the high cost of these life-changing therapies, and that copay assistance programs mask larger cost and affordability issues in the health care system. However, strategies to lower costs and spending — known as cost containment strategies — unfairly place patients in the middle of a fight that belongs among insurers, manufacturers, and pharmacy benefit managers. The tactics insurers often use, like co-pay accumulator programs, can result in undue financial burden for the patient.
The HELP Copays Act would help lower out-of-pocket costs for people with CF in two important ways:
- Restrict co-pay accumulator programs and require health insurance plans to count the total value of any co-pay assistance received toward the enrollee’s annual deductible and out-of-pocket maximum
- Ensure that any item or service covered by the health plan is considered part of their essential health benefits package, therefore protecting patients from current practices that exclude coverage of CF specialty medications
After providing comments to the Department of Health and Human Services earlier this year, the CF Foundation was pleased to see HHS finalize the 2025 Notice of Benefit and Payment Parameters (NBPP), clarifying that prescription drugs covered by a health plan are considered essential health benefits and subject to cost-sharing protections for marketplace and small group plans. We await a ruling from the Departments of Labor, Treasury, and HHS that will provide additional guidance for large group and self-insured plans.
Despite a recent court decision requiring health plans and pharmacy benefit managers to count co-pay assistance toward patient cost-sharing, HHS has yet to enforce this rule. This has left patients uncertain about their true out-of-pocket expenses when making payments throughout the plan year. As a result, the Foundation urges HHS to enforce the co-pay assistance provision included in the 2020 NBPP to ensure treatment access and affordability for those living with CF.
Once the Administration issues guidance enforcing cost-sharing requirements, Congress must swiftly pass the HELP Copays Act to ensure all cost-sharing on behalf of a patient is counted toward their annual deductible and out-of-pocket maximum across all plan types, and that any item or service covered by a patients’ health plan is considered part of their essential health benefits package, fixing an important glitch in the Affordable Care Act.