The ACR has strongly supported the IRA and its provisions related to drug price negotiation, and we will continue to strongly defend it once the new administration and Congress are seated.
Copay Accumulators
In 2021, the CMS issued a final rule that allowed payers to operate copay accumulator programs and deferred to state law on their regulation. However, in 2023, a federal district court ruling struck down the 2021 rule, legally precluding payers from implementing copay accumulators for drugs that lack generic equivalents. However, as of the 2026 Notice of Benefit and Payment Parameters Rule, the CMS has opted not to enforce the court ruling.
Biosimilar Interchangeability
In the summer of 2024, the U.S. Food & Drug Administration (FDA) finalized guidance that removed a requirement for a switching study for demonstrating biosimilar interchangeability. For a biologic product that is administered more than once to an individual, a switching study refers to a clinical study used to determine the impact of alternating between the reference product and the proposed interchangeable biosimilar compared to using the reference product without any such alternation. The new guidance provides recommendations to applicants for proposed interchangeable biosimilar products that would eliminate the need for a switching study.
The ACR cautiously supported this new approach, because switching studies have become superfluous and represent a barrier for patient access to biosimilars. However, we strongly urged the FDA to ensure strict guardrails are upheld to maintain transparency and patient safety.
Antitrust/Pharmacy Benefit Manager Reform
Regulatory agencies are closely examining mergers and acquisitions within the healthcare industry to address potential anti-competitive practices and impacts on patient access and costs. They are also increasing scrutiny on private equity firms’ ownership structures within healthcare facilities and potential impacts on patient care and pricing.
Healthy Competition has been launched by the Federal Trade Commission (FTC), the U.S. Department of Justice (DOJ), and the HHS to allow individuals to report potential healthcare competition concerns. The DOJ has also launched a task force to investigate and address healthcare market consolidation. Additionally, the FTC released an interim report detailing how pharmacy benefit managers (PBMs) have manipulated drug formularies and bottlenecked patient access to necessary treatments.
Underwater Biosimilars Coalition
In the summer of 2024, the ACR joined forces with the Coalition of State Rheumatology Organizations to form the Underwater Biosimilars Coalition, a diverse group of more than 40 patient organizations and specialty societies that have grave concerns regarding the inadequate (or “underwater”) reimbursement of certain Medicare Part B biosimilars under the current average sales price (ASP) methodology and its impact on access to care. The Coalition’s goal is to recommend to regulatory agencies and Congress potential solutions intended to broaden the use of biosimilars. The Coalition has held meetings with the CMS, the Medicare Payment Advisory Commission and the White House Office of Management & Budget and has initiated a letter-writing campaign that has included the CMS and will now pivot to the new Congress.
