Dear Secretary Bessent, Secretary Chavez-DeRemer, and Secretary Kennedy:
The Cystic Fibrosis Foundation thanks the Department of Treasury, Department of Labor, and Department of Health and Human Services (“the Departments”) for the opportunity to respond to the Request for Information on issues regarding the Transparency in Coverage Final Rule and offers several comments below to improve and enhance transparency of prescription drug information for patients and other stakeholders.
Cystic fibrosis is a rare genetic disease that affects nearly 40,000 people and can affect every racial and ethnic group in the United States. In people with CF, mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene result in a buildup of thick mucus in multiple organ systems, leading to lung damage, life-threatening infections, and other complications. As a complex, multi-system condition, CF requires targeted, specialized treatment and medications. If left untreated, infections and exacerbations caused by CF result in irreversible lung damage, and the associated symptoms of CF lead to early death, usually by respiratory failure.
Transformative therapies — such as CFTR modulators, which have no generic or therapeutic alternatives available — have been paramount in changing what it means to live with CF. We are seeing signs that the cost of some prescription drugs is not sustainable, and there is growing resistance from plans to cover some specialty drugs. However, health plan cost containment strategies and the lack of transparency have created a convoluted system that patients struggle to navigate and often results in significant barriers to care.
Transparency in Coverage Final Rules
We appreciate the Departments attention to promoting greater price transparency in healthcare and empowering patients with the information they need to best understand their coverage. Nonetheless, there are several ways in which the Transparency in Coverage rules could be improved to help patients, including aligning coverage reporting requirements with the marketplace, expanding opportunities for public compliance reporting, standardizing dosage reporting units, and requiring public reporting of third-party entities involved in providing health coverage.
Approximately 60% of all people with CF are on a private health insurance plan so the Transparency in Coverage rules have the ability to significant enhance our community’s understanding of their coverage. Prior to these rules, the prices paid for health care — generally set through negotiations between insurer or employer health plans(or their third-party administrators) and in-network health care providers — were considered proprietary. The final rules required payers to develop machine-readable files (MRFs), which were intended to benefit the public by delivering “more targeted oversight, better regulations, market reforms to ensure healthy competition, improved benefit designs and more consumer-friendly price negotiations.” However, since implementation, the MRFs available are challenging to access and use, greatly limiting the value of the data collected.
Moreover, there is increased pressure on patients to make informed choices about their care and prescription drug medications, but there is very little transparency to guide patients as they navigate our health system. This is demonstrated by the findings of a 2024 survey of the CF community; nearly a third of people with CF reported that it was challenging to understand what they will have to pay out-of-pocket for their CF care. Further, of those who reported delaying care in the past year, insurance denials (38%) and the cost of co-pays (37%) were among the top reasons contributing to this delay. By having clear information on the requirements for obtaining specialty medications, including lay-friendly documentation on what drugs are covered and any associated cost-sharing or coverage requirements, such as step therapy or other utilization management criteria, patients can access their treatments more efficiently without undue burden. Transparency around formulary design would also allow patients and their health care providers to have confidence that clinical evidence is driving coverage decisions. Additionally, this transparency could give advocates and researchers the information and data they need, and facilitate system-level reforms as needed.
We provide the following comments and recommendations in response to the request for information.
- Improvements to disclosure requirements: Are there existing data elements described in 26 CFR 54.9815-2715A3(b)(1)(iii), 29 CFR 2590.715-2715A3(b)(1)(iii), and 45 CFR 147.212(b)(1)(iii) that would be more useful if reported in a different form or manner? Are there ways to simplify the reporting schema to streamline disclosure to relieve reporting burdens? What are the appropriate metadata elements that should be required to be associated with the public disclosure file? Are there any improvements to disclosure requirements that would be particularly useful to interested parties including consumers, employers, and other purchasers of health care?
There are consistently issues with payers disclosing data in an incomplete or inaccurate manner. For example, some payers do not update this data monthly, while other payers do not provide information on the full prescription drug benefit. These inconsistencies make it difficult for consumers to fully understand the true cost of their essential medications.
Standardization to Improve Utility
Standardized benefit information has already been developed for marketplace health plans. This same format should be required for all health plans and linked to the MRF data. This should include details on benefit design such as the commercial health plan name, covered population, and general cost sharing information such as copays and deductibles. Lack of standardization makes it difficult for people with CF and their families to compare the true cost of a plan.
Enhance Quality and Compliance
To improve compliance with the disclosures already required, we recommend the Departments enhance opportunities for compliance. This includes allowing members of the public to report non-compliance. The federal government is responsible for monitoring compliance; however, it struggles to review and assess all the data given the volume of documents plans are uploading. We know many payersiii currently fail to meet key elements of the final rule. Patients, providers, and advocacy organizations reviewing data should be able to report violations directly to the Departments, who must then investigate and issue fines if violations persist. Further, we recommend the Departments require payers to include contact information to get answers to questions about the data. Many of the compliance issues and mismatched data issues could be resolved by providing direct contact information to address data concerns without relying on government review.
- Disclosure of dosage units: How do plans, issuers, and PBMs store and manage pricing information for dosage unites of prescription drugs? Should the Departments require a standardized format for disclosing dosage units and supply periods for prescription drugs ( e.g., by 7-day, 30-day, or 90-day supply, by each dosage, or some other standardized dosage unit)? Should the Departments require disclosure of the quantity of the drug on which the price is reported?
Payers are not required to post dosage unit information, making it hard to understand and unreliable to compare prices. It is unclear whether the prices for a given drug are measured by a consistent unit across different insurers and plans, especially for drugs with multiple indications, in which each unique indication may correspond to a unique dosage. This limitation creates a significant barrier to comparing prices across insurers and plans. For example, the majority of people with CF are prescribed a pancreatic enzyme replacement therapy (PERT) to manage exocrine pancreatic insufficiency caused by the disease. There are multiple different PERTs available and, while the active ingredient is the same across PERTs, patients experience clinically significant differences in how they respond to individual products. Variations in formulation — including enzyme content, particle size, delivery, and enteric coating — can lead to differences in how well patients absorb nutrients. Further, PERT dosing may be done based on diet and weight. These many factors can result in wide variation in PERT usage in the CF community and, when payers do not standardly disclose prices based on drug quantity or dosage, it is exceedingly difficult for any given person with CF to understand what their out-of-pocket costs will be for this necessary treatment. Therefore, we recommend adding consistent drug unit, indication, identification of drug product, and more clarification on type of drug prices to improve the quality of disclosed pricing information.
- Identification of entities: Should the Departments require plans and issuers to identify the PBM or other service provider, if any, that manages a plan's or coverage's pharmacy benefits, to facilitate better comparison of prices and data between plans and coverages? Would there be any benefit or burden associated with requiring a plan or issuer to identify pharmacies that are affiliated with the plan's or coverage's PBM and would such benefit be worth the added burden?
We strongly support the Departments requiring plans and issuers to identify the entity that manages a plan’s pharmacy benefits. The opacity in contracting arrangements makes it difficult to assess the role PBMs and other third-party entities play in drug pricing and access. Most insurers contract with PBMs to handle the administrative side of their drug benefit provisions. But PBMs have no obligation to share details with insurers about how the PBM determines formulary placements and why some drugs in the formulary cost more than others. This lack of transparency on the role of PBMs causes confusion on the appropriate point of contact for appealing coverage decisions, increases the administrative burden on people with CF, and may cause gaps in access to important therapies. We recommend the Departments work with Congress to help implement comprehensive PBM reforms that prioritize patients by increasing not just transparency, but also oversight of the prescription drug supply chain.
Transparency is also crucial to help patients understand their pharmacy network when choosing an insurance plan. People with CF have numerous daily treatments, some of which are limited distribution and can only be filled at select pharmacies. When PBMs restrict their members to their preferred specialty pharmacy, it requires people with CF to navigate going to the limited distribution pharmacies for specific medications and then the preferred pharmacy for other treatments. Having multiple pharmacies for chronic medications requires significant coordination to the person with CF or caregiver, increasing administrative and time burden. While this issue is not solely the result of PBM practices, increased transparency on ties between PBMs and pharmacies will allow for more informed decision making among consumers and may potentially alleviate some of this burden.
Furthermore, providing increased transparency around all entities involved in managing pharmacy benefits will help patients understand the role of third-party entities such as alternative funding programs (AFPs) and maximizers that handle part or all of their specialty drug benefit. These entities exist to lower costs for health plans but also add complexity to an already opaque system for patients. Maximizers often subcontract a patient’s drug coverage to a third-party entity that sets the patients’ cost-sharing at a level to maximize use of manufacturer copay assistance. AFPs seek to source high-cost drugs by enrolling patients in manufacturer patient assistance programs that provide free drugs, which are usually intended for people without insurance. AFPs cause consumers to experience financial losses and lose access to critical medications while they navigate these programs. When a patient is forced to enroll in a third-party program, any financial assistance the patient receives will not be counted towards meeting their deductible or out-of-pocket limit, increasing the cost burden for the patient. Requiring issuers and plans to identifying these third-party drug benefit service providers as part of the overall plan design would help patients better navigate this highly complicated system.
Conclusion
Thank you for the opportunity to provide information on the experiences of people with CF. While the current transparency measures and any additional changes as a result of the RFI are a good first step, we strongly urge the Departments to work across federal agencies and with Congress to increase oversight and accountability for health plans, TPAs, PBMs, and other third-party entities. The CF Foundation is ready to serve as a resource as the Departments explore solutions to improve affordability and access to essential therapies.