Copay accumulators, maximizers and best price concerns dominated the copay assistance landscape in 2021. Challenges abounded in the form of patient adherence impact, negative gross-to-net effects for manufacturers, and a legal and policy backdrop that was ever-changing. As the biopharmaceutical industry moves through 2022, addressing each of these issues will become increasingly important given their intertwined impacts in the near future.
Here is an update on the most prominent developments in this area over the last six months.
Accumulators Will Remain for the Foreseeable Future
The Centers for Medicare and Medicaid Services (CMS) solidified these tactics' place in the market via the latest annual Notice of Benefit and Payment Parameters rule. Despite significant pressure to reverse existing accumulator provisions from the All Copays Count coalition, a consortium of patient advocacy groups and a letter to President Biden signed by multiple members of Congress from both parties calling for the same, CMS made no changes. TrialCard's copay program data, encompassing 99 specialty brand programs across 13 therapeutic classes, revealed total accumulator-impacted patients increased from 4.5% in 2020 to 8.6% in 2021. Total maximizer-impacted patients increased from 2.7% to 4.3% over that same time. In keeping with prior year-over-year trends, combined with a recent MMIT study indicating that 80% of commercial plans had accumulators available in their benefit design in 2021 with 43% of plan sponsors electing to implement them, an increase from 67% and 39% the year prior and 44% and 28% respectively in 2018, these tactics appear poised to remain a challenge for patients and manufacturers alike.
Several states have enacted or proposed legislation outlawing these practices. However, state anti-accumulator laws are limited in scope only to fully-insured plans. Self-funded plans, such as most employer-sponsored coverage, are not subject to these laws as they are governed by the Employee Retirement Income Security Act. In November 2021, Rep. Donald McEachin (D-VA) introduced the Help Ensure Lower Patient Copays Act at the federal level. If passed, this legislation would ban accumulators in all plans. As of the publication date of this article, no action has been taken on this piece of proposed legislation.
Manufacturers and copay program providers are paying particular attention to whether these tactics make their way to provider-administered therapies covered under the medical benefit. United Healthcare sought to do exactly that in 2021, but reconsidered in the face of immense provider pushback. The prevailing sentiment within the industry, however, is that insurers will eventually make more attempts to manage medical benefit products in the same way as their pharmacy benefit counterparts with respect to copay assistance.
Continued Evolution of Maximizers
Maximizers have gained increased popularity among plan sponsors in recent years. They saw a significant acceleration in 2021, primarily because they allow the plan sponsor to advertise a $0 out-of-pocket obligation to patients. Another selling point is that in their most basic form, they avoid the "copay cliff" that befalls patients with traditional accumulators. This approach is changing, however. Manufacturers have recently started combating maximizers' gross-to-net impact by reducing available copay assistance once a patient is identified as being in a maximizer plan. In turn, maximizers have become more aggressive in capturing as much of the copay offer benefit in the first few claims as possible, to guard against having to absorb the cost for more patients later in the year. Further, SaveOnSP, the maximizer program aligned with Express Scripts, moved from a static copay amount model to a percentage coinsurance design for 2022, mirroring that of PrudentRx.
Manufacturers have also incorporated more explicit program terms and conditions around maximizer programs, in a demonstration of intent largely believed to be pre-positioning to avoid forthcoming best price impact. Some provisions state that patients identified as part of maximizer programs will receive a lesser benefit, and that the offer value can be reduced or rescinded at any time. Other terms are so detailed that they indicate the health plan is agreeing that by accepting reimbursement from the program, it is to be credited only towards patients' cost-sharing obligations.
Best Price Uncertainty on Multiple Fronts
The issues caused by accumulators and maximizers stand to become compounded in less than a year. Beginning in 2023, manufacturers are required to include the value of their copay assistance offers in best price calculations unless they ensure the benefit of the offer are provided entirely to the patient, as mandated by a CMS Final Rule published in December 2020. Since the rule's publication, manufacturers have been scratching their collective heads seeking solutions that do not cause a more complicated experience and increased financial burden for patients. CMS suggests offering a rebate model, whereby patients pay out of pocket and receive direct reimbursement from the program, outside of the pharmacy claim. But given the high-cost outlay required, this method will not support many patients. TrialCard met with CMS to discuss the operational details of the rule in 2021, but the agency offered little in the way of guidance. Rather, it maintained the position that manufacturers are responsible for ensuring their programs benefit patients and need to do so within the existing industry ecosystem.
The Pharmaceutical Research and Manufacturers of America (PhRMA) filed a lawsuit challenging the rule in May 2021. TrialCard filed an amicus brief in support of PhRMA's position, as did another copay program provider. The uncertain outcome and timetable of the lawsuit, however, add another layer of complication for manufacturers. Changing program designs and operational processes to be compliant takes months of lead time. Work on such updates must begin soon to be in place by the turn of the year, meaning manufacturers will not have the luxury of waiting for the outcome of the lawsuit to determine whether to modify program design.
TrialCard continues to closely monitor developments in this area. Reach out to [email protected] to understand how each of these issues will affect your copay program and learn about solution options to ensure compliance and continued patient access and affordability.