Dear Secretary Becerra and Administrator Brooks-LaSure:
The Cystic Fibrosis Foundation thanks the Centers for Medicare and Medicaid Services (CMS) for the opportunity to respond to the Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems Proposed Rule and Request for Information (RFI). 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.
About Cystic Fibrosis
There are close to 40,000 children and adults living with cystic fibrosis in the United States, and CF can affect people of every racial and ethnic group. Cystic fibrosis is a life-threatening genetic disease that causes the body to produce thick, sticky mucus that clogs the lungs and digestive system, which can lead to life-threatening infections. Cystic fibrosis is both serious and progressive; lung damage caused by infection is irreversible and can have a lasting impact on length and quality of life. As a complex, multi-system condition, CF requires continuous targeted, specialized treatment and medications, and continuous coverage and prior authorization reforms are both important policies for facilitating access to care.
Continuous Coverage
The Cystic Fibrosis Foundation supports the CMS’s proposal to provide 12-month continuous eligibility for children in Medicaid and CHIP. Continuous eligibility protects patients and families from gaps in care and promotes health equity. The impact of eligibility redeterminations on the Medicaid population has made continuous eligibility especially important as many are at risk of losing coverage. This rule will help to eliminate coverage gaps that often occur when individuals transition from Medicaid to marketplace coverage; research shows that individuals with continuous coverage experience fewer unmet healthcare needs and are in better health than those who cycle on and off coverage.
Research has shown that individuals with disruptions in coverage during a year are more likely to delay care, receive less preventive care, refill prescriptions less often, and have more emergency department visits. Gaps in Medicaid coverage have also been shown to increase hospitalizations and negative health outcomes for ambulatory care-sensitive conditions like respiratory diseases and heart disease. Additionally, continuous coverage can help avoid higher healthcare costs resulting in delayed care. These policy proposals are designed to minimize “churn,” which elevates the risks of uninsurance and the loss of regular health care.
Consistent care and access to specialized therapies are necessary for people with cystic fibrosis, and any loss or gap in coverage — even for as little as one month — may put people with CF at risk of declining health by forcing them to forgo daily therapies due to cost. For example, 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 an increased risk of lung exacerbations, irreversible lung damage, and costly hospitalizations.
Moreover, studies show that children of color are more likely to be affected by gaps in coverage that continuous eligibility would address, rendering it crucial for increasing equitable access to care. Overall, multi-year continuous eligibility would improve access to and continuity of care for children during the critical early years of life while promoting health equity. Because of the importance of this policy, the Foundation also urges CMS to track rates of churn for children to help evaluate the effectiveness of this policy.
Improving Prior Authorization Processes
Prior authorization is a time-consuming process that can burden providers, divert valuable resources away from direct patient care, and cause delays in patient access to needed treatment. This process is particularly burdensome on the CF community as people with CF must adhere to intensive, ongoing treatment plans in order to stay healthy. Prior authorization policies present a unique set of challenges for people with CF and other lifelong, chronic diseases. For CF patients, their diagnosis will never change; they will take many of the same drugs throughout their lifetime and it is unnecessary to require providers to continuously request reauthorizations and provide duplicative information in order to demonstrate the medical necessity of these therapies.
We appreciate CMS’ efforts to align Medicare’s prior authorization request for fee-for-service hospital outpatient services with the CMS’ recently finalized Interoperability and Prior Authorization Final Rule to seven calendar days, instead of 10 business days. While we agree this will streamline the prior authorization process so that it is the same across payers, the CF Foundation recommends CMS shortening this timeline to 24 hours for expedited review, and 48 hours for standard review, similar to that of prior authorization requests for Medicare Part B drug review. For people with CF, delays in obtaining services and treatments can result in clinical decline and the potential for negative health outcomes. According to preliminary evidence from the CF Foundation patient registry, a 7-day interruption in one patient’s chronic CFTR modulator treatment resulted in a significant decrease in lung function, a worsening cough, and a hospitalization requiring intravenous antibiotics. It is imperative that prior authorizations are not a cause of delayed treatment and that they are promptly reviewed with the decision shared in a transparent manner to both the provider and patient.
To further expedite the prior authorization process, we recommend CMS explore options such as “gold carding” or automatically approving prior authorizations for providers that have a demonstrated history of prior authorization approvals. As stated, cystic fibrosis has no cure and people with CF take their medications chronically. Further, these medications have clear indications about which patients should take them and do not provide benefit for those who do not meet eligibility requirements. Having to regularly go through the reauthorization process for life-long treatments causes significant time and administrative burden on both patients and providers. The time care teams spend on treatment authorizations is unnecessary for diseases such as cystic fibrosis and would be better spent providing clinical care. We request that CMS continue to explore ways, such as gold carding, to eliminate this burden and ensure providers are spending their time providing the high-quality care that people with CF require.
The CF Foundation appreciates the opportunity to provide comments on the proposed rule. We look forward to working with CMS on these critical issues to ensure access and affordability for people with CF.