Dear Mr. President,
On behalf of the 40,000 children and adults living with cystic fibrosis in the United States I would like to welcome you back as President of the United States. The Cystic Fibrosis Foundation looks forward to continuing working with you and your Administration on issues that impact the CF community.
The CF Foundation is a national organization dedicated to curing cystic fibrosis and providing all people living with the disease the opportunity to lead full, productive lives by funding research and drug development, promoting individualized treatment, and ensuring access to high-quality, specialty care. We look forward to working with you to advance policies that will achieve these goals.
Cystic fibrosis is a progressive, genetic disease that affects the lungs, pancreas, and other organs, and it can affect people of every racial and ethnic group. CF causes the body to produce thick, sticky mucus that clogs the lungs and digestive system, which can lead to life-threatening infections. CF also affects multiple systems in the body and people living with the disease often suffer from chronic pancreatic insufficiency, malnutrition, diabetes mellitus, liver disease, bone disease, and other comorbidities. As a complex, multi-system condition, CF requires targeted, specialized treatment and medications. While advances in CF care are helping people live longer, healthier lives, there is no cure.
As you move forward with your policy priorities, we urge you to take into consideration the needs and challenges facing individuals living with cystic fibrosis and their families. We raise for your consideration the CF Foundation’s top priorities.
- Provide robust funding and support to federal agencies, particularly the National Institutes of Health (NIH) and the Food & Drug Administration (FDA).
- The NIH and FDA play a vital role in the CF story of progress and transformation, from discovery of the CF gene to bringing new CF therapies into the hands of patients safely and effectively. Adequate agency funding is necessary to allow experts in the public health space to continue to utilize their skill, training and experience to support robust public health protection efforts and drug approvals. We support the maintenance of existing agency funding, including adequate annual appropriations and renewal of user fees to allow agencies' the continued ability to support people with CF through scientific advancement and public health protections.
- Increase access to adequate, affordable care by:
- Maintaining access to Medicaid for the nearly 40% of patients with CF who rely on the program to afford their care. We ask that you resist funding cuts and adding administrative barriers to this program, including per capita caps and work reporting requirements, that could cause some patients with cystic fibrosis to lose this critical health coverage. These changes could eliminate a critical source of coverage that helps ensure patients have the treatments prescribed by their care team.
- Supporting extension of the Affordable Care Act’s advanced premium tax credits that were enhanced to increase the amount of premium assistance available to those who qualify and to extend eligibility for those above 400% of the federal poverty level so patients can access more affordable options. To access high quality, specialized care, people with CF need adequate, affordable insurance. This ensures that people with CF do not face delays in treatment, which can be detrimental to their health, and at time, life threatening. These enhanced credits are currently set to expire in 2025 and would result in comprehensive coverage losses for four million Americans.
- Maintain limits on availability of short-term limited durations plans. Short-term limited duration plans are exempt from many important consumer protections and often do not cover essential care, like prescription drugs or mental health services, and allow insurers to penalize consumers with pre-existing conditions, like those living with CF. As such, these plans should be limited to short-term use, as allowed under current rules.
- Prioritize patients in pharmacy benefit manager reform discussions by:
- Supporting policies that would require payers to apply third-party assistance to out-of-pocket maximums and other patient cost-sharing requirements, while ensuring any item or service covered by a health plan is considered part of their essential health benefits package;
- Increasing transparency measures for PBMs and insurers to guarantee patients receive better information about coverage policies for specialty drugs;
- Delinking a PBM’s compensation from the manufacturer’s list price for all plan types;
- Banning spread pricing across all plan types to prevent insurers from being charged more for a prescription drug than the pharmacy is reimbursed which often leads to inflated drug costs for patients;
- Ensuring accountability through reporting requirements that would allow entities to hold PBMs accountable and respond when policies are not operating in the patient’s best interest; and
- Giving patients a seat at the table, whether that comes in the form of in-person testimony, constituent meetings, or patient roundtables, we ask that your Administration consider the patient experience into all reforms.
- Address the urgent need for novel antimicrobials.
- Infection is a hallmark of life with CF. We support policies that work to improve reimbursement for antibiotics and invest in innovative payment models that incentivize the development of novel antimicrobials, including antibiotics and antifungals, and we look forward to partnering on this issue.
- Expand access to telehealth services by:
- Permanently removing the originating site requirement and geographic restrictions to ensure a patient’s home can serve as the site of care;
- Continuing to expand access to audio-only telehealth visits; and
- Expanding licensure reciprocity for those who rely on out-of-state care centers to help manage their care.
Again, we want to welcome you back to Washington, D.C. The CF Foundation looks forward to working with you and your Administration throughout your term.