Dear Secretary Becerra and Acting Secretary Su:
On behalf of the nearly 40,000 children and adults in the United States living with cystic fibrosis, the Cystic Fibrosis Foundation urges the Department of Health and Human Services (HHS) to quickly issue guidance clarifying to health insurance issuers across all plan types (including individual, small group, large group, and self-insured) that they must follow the copay assistance provision included in the 2020 Notice of Benefit and Payment Parameters (NBPP) – 45 C.F.R. § 156.130(h); version effective from June 24, 2019 to July 12, 2020. Further, these plan issuers must inform enrollees subject to a copay accumulator adjustment policy of this change. This is particularly urgent as enrollees are at the beginning of their plan year and budgeting for their healthcare needs in 2024.
CF is a life-shortening genetic disease that causes the body to produce thick, sticky mucus that clogs the lungs and digestive system. This can lead to lung damage, life-threatening infections, malnutrition, and other complications. CF is both serious and progressive; lung damage caused by infection is often irreversible and can have a lasting impact on length and quality of life, resulting in extended hospitalizations, transplant, or premature death. As a complex, multi-system condition, CF requires specialized treatment and medications, which have contributed to significant gains in average life expectancy for people with cystic fibrosis over the last few decades. 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.
The lack of communication from the administration has left patients uncertain what the true out-of-pocket may be when comparing plans. As you know, accumulator adjustment policies 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 adjustment policies 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 manufacturer and nonprofit copay assistance programs mask bigger cost and affordability issues in the health care system. However, 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. HHS should further require issuers across all plan types 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.
The Cystic Fibrosis Foundation looks forward to working with you on these actions to ensure treatment access and affordability for people with CF.