Dear Honorable Members of the Vermont Senate Committee on Health and Welfare:
On behalf of the nearly 150 people living with cystic fibrosis in Vermont, we write to express our support for H 766 and H 233. The first, H 766, makes several important reforms to the prior authorization (PA) process. PAs can delay access to critical CF therapies and the Cystic Fibrosis Foundation supports efforts to minimize the administrative burden PAs impose on patients and their providers and ensure access to therapies for people living with CF. The second, H 233, would require insurers to apply third-party assistance to out-of-pocket maximums and other patient cost-sharing requirements. While we recognize that copay assistance is problematic — it allows pharmaceutical companies to charge payers high prices while shielding many individual patients from the costs — patients with chronic diseases like CF often struggle to afford their care and rely on copay assistance to access vital medications. H 233 will help ensure patients’ health and financial wellbeing are not sacrificed in the ongoing, systemic debate between payers and pharmaceutical companies about prescription drug pricing.
About Cystic Fibrosis
Cystic fibrosis is a life-threatening genetic disease that affects nearly 40,000 children and adults living with cystic fibrosis in the United States, and CF 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 care is grounded in evidence-based clinical guidelines and as a complex, multi-system disease without a cure, CF requires an intensive treatment regimen including multiple medications. For people with CF, it is not uncommon to take seven therapies every day, and as many as twenty. Many medications are taken year after year, and in most cases, for life. While advances in CF care are helping people live longer, healthier lives, we also know that the cost of care is a barrier for many people with the disease.
H 766: Prior Authorization Reform
Prior authorizations are one of the obstacles people with CF must navigate when accessing care. These requirements can delay the start or continuation of needed treatments, which can lead to adverse health outcomes. In a 2022 survey by the American Medical Association, 94 percent of physicians reported that prior authorizations led to delays in necessary care for their patients whose treatment required PA and 80 percent reported that PAs have led to patients abandoning their treatment at some point. Because CF is a progressive disease, patients who delay or forgo treatment — even for as little as a few days — face increased risk of lung exacerbations, costly hospitalizations, and potentially irreversible lung damage.
PAs can also cause significant administrative burden for CF providers and are often redundant for medications that people with CF must take indefinitely to maintain their health. In a 2019 CF Foundation survey of over 100 CF care center directors, 60 percent cited the time and resources required for prior authorizations as one of the biggest barriers they face in supporting access to care and treatment. This arduous process diverts valuable time and resources away from direct patient care.
The Foundation understands that payers adopt prior authorization policies to ensure patients only receive medically necessary care, and we recognize the challenge insurers face in opportunity to make prior authorization processes more efficient, allowing for timely access to appropriate treatments. We appreciate Vermont’s attention to this issue and support the following provisions in H 766:
Length of Treatment PAs
Recognizing that people living with CF and other lifelong, chronic diseases take the same drugs for most of their lives, we appreciate that H 766 requires that prior authorization approvals be valid for the duration of a course of treatment or one year, whichever is longer. This bill also provides an opportunity for continued approval by exempting prescribed treatments that continue for more than a year from PA renewals for five years. Eliminating unnecessary repeat authorizations will help promote immediate and consistent access to life-saving therapies for people with CF, and significantly reduce administrative burden for CF care teams.
Exemptions for Certain Services
To further reduce administrative burden and delays in care, H766 exempts a service from prior authorization requirements if it has low variation across providers and denial rates are less than 10 percent across carriers. We support the concept of eliminating PAs for services with high approval rates and ask that the legislature further clarify the low variation requirement. Because cystic fibrosis requires highly specialized care and treatment, most people with CF receive care at a CF Foundation-accredited care center, which provide quality, specialized CF care that is based in clinical guidelines. If a medication or treatment for people with CF was exempted from prior authorization requirements, care teams could spend more time on patient care instead of paperwork and, most importantly, people with CF could avoid delays in care.
Response Times and Continuity of Care
H 766 requires health plans to respond to urgent prior authorization requests within 24 hours and two business days for non-urgent requests, thereby ensuring timely access to emergency treatments. The Foundation asks the legislature to amend the requirements for insurers to respond to non-urgent requests to within 48 hours to reflect model legislation prepared by the American Medical Association. Also included in the bill is a continuity of care provision that protects patients from experiencing care delays when there are changes in coverage or when patients switch health plans. Gaps in therapy put people with CF at increased risk of costly hospitalizations and negative health outcomes. We support efforts to reduce delays in care and ensure people have timely access to their necessary medications.
H 223: Co-pay Accumulator Ban
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 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—even for as little as a few days — face increased risk of lung exacerbations, costly hospitalizations and potentially irreversible lung damage.
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.
H 233 would also require covered benefits to be considered essential health benefits (EHBs). Currently, private health plans are allowed to deem certain categories of prescription drugs as “non-essential.” This tactic allows plans to substantially adjust their cost-sharing for a particular drug or eliminate coverage for certain specialty medications altogether. In doing so, plans can require enrollees to seek free drug from manufacturers or collect the maximum amount of copay assistance available through manufacturer and other third-party programs. These strategies include an accumulator component, which adds to the considerable cost and administrative burdens for people with CF. Cystic fibrosis treatments rarely have lower-cost generic alternatives and, when private plans exclude specialty CF medications or cover them while placing significant administrative and financial burden on the enrollee, people with CF face the difficult choice of foregoing these necessary treatments, changing to an often more costly insurance plan from the marketplace, or in some cases seeking alternate employment.
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, 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. The situation has become even more dire as a company that manufactures CF therapies recently reduced the amount of copay assistance available for people enrolled in accumulator programs.
We urge you to support H 766 and H 233. Together, these bills will improve access to care and treatments for people with CF while reducing administrative burdens on providers, allowing them to spend less time on paperwork and more time caring for their patients.