The constantly evolving copay support landscape is leaving many brand managers and patient support teams wondering how to stay one step ahead of cost shifting strategies that are affecting their patients. Payers have set up a labyrinth of obstacles — ever-expanding exclusion lists, prior authorizations, step edits, and a complicated appeals process — making it difficult to access branded drugs.
Obstacles in Accessing Branded Drugs
Exacerbating these challenges are copay adjustment programs like accumulators and maximizers, which block a manufacturer's copay support from fulfilling patients’ deductibles and out-of-pocket-maximum obligations. The legal battles over accumulators and maximizers are ongoing, but we are starting to see some indications of how these lawsuits are likely to play out over the coming year, both at the state and federal levels.
According to the National Conference of State Legislatures, laws in 20 states and Puerto Rico have been passed to address the use of copay adjustment programs by insurers or PBMs; these laws require that any payment or discount made by or on behalf of a patient must be applied to the consumer’s annual out-of-pocket deductible. We expect this trend of state-enacted anti-accumulator laws to continue, with 24 states banning accumulators by 2024, up from just 5 in 2020. If our “24 in ’24” prediction is correct, approximately 30 million patients will be shielded from ever having to face an accumulator when purchasing their medication.
Federal Action: The HELP Copays Act
We’re hopeful that this state-level momentum will also have an impact in Washington, DC, and recent federal action is encouraging. H.R. 830, the Help Ensure Lower Patient Copays Act, or the HELP Copays Act, was re-introduced in the new Congress in early 2023. Simply stated, the bill requires health insurance plans to apply certain payments made by, or on behalf of, a plan enrollee toward a plan's cost-sharing requirements. Specifically, plans must apply third-party payments, financial assistance, discounts, product vouchers, and other reductions in out-of-pocket expenses toward the requirements.
An array of patient support advocates are championing the bill, including the Safe Step Act Ad Hoc and All Copays Count coalitions, comprising over 200 patient and provider organizations seeking to improve access and affordability for medically necessary treatments. In April 2023, these coalitions sent a letter urging inclusion of the group's policy priorities in legislation being drafted by the U.S. Senate Health, Education, Labor and Pensions Committee that seeks to reform the PBM industry. Importantly, the Help Copays Act is one of their top priorities.
Despite this strong support, the Help Copays Act still has a long way to go. Given how early we are in the process, our experts give this bill a 25% chance of becoming law.
Progress in the National Lawsuit Against Accumulators
Comparatively speaking, the case of HIV and Hepatitis Policy Institute et al. v. U.S. Department of Health and Human Services et al is much further along in its efforts to ban accumulators nationally. Filed a year ago, the plaintiffs allege that accumulators violate the Affordable Care Act and Administrative Procedure Act, while defendants believe eliminating accumulators will “encourage patients to use more expensive medications over less costly treatments, and also contribute to higher drug and health care spending and thus higher premiums.”
Soon after the filing, HHS appealed to the court asking for the case to be dismissed on the grounds that the plaintiffs failed to allege concrete damages as a result of the accumulator policies. The judge, however, disagreed and declared the case can continue. Overcoming this hurdle was a significant step in this case for anti-accumulator advocates, and because of this, there is a chance that this case will be ruled for the plaintiffs.
Finally, we’ll keep our eyes on the ongoing lawsuit between Johnson & Johnson (J&J) and SaveOnSP. Originally filed in 2022, J&J’s lawsuit notes that similar to other maximizer programs, SaveOnSP blocks the funds from counting toward patient annual deductibles. J&J claims that SaveOnSP defrauded J&J’s copay assistance program by increasing patients’ copay amounts and pushing them to enroll in the MCAP program. J&J is seeking monetary compensation and an injunction against SaveOnSP. In January 2023, a New Jersey federal court denied SaveOnSP’s request to dismiss the case. We currently see this case as a 50/50 toss-up.
The Future of Accumulators and Maximizers
Regardless of the outcomes of these predictions, the ongoing legal battles are sure to change the accumulator and maximizer landscape in the coming year and beyond.
To learn more about how accumulators and maximizers continue to impact the patient landscape, join ConnectiveRx on October 26th for a free online panel discussion: The Battle Over Accumulators and Maximizers: What You Need to Know for 2024. On-demand access will also be available by registering.