Co-Pay Accumulators, Maximizers, and the CMS Best Price Rule: What You Need to Know Now

Copayment accumulators, maximizers, and best price concerns dominated the copayment aid landscape in 2021. Challenges abounded in the form of impact on patient adherence, gross to net negative effects for manufacturers and an ever-changing legal and policy environment. As the biopharmaceutical industry moves forward into 2022, addressing each of these issues will become increasingly important given their interrelated impacts in the near future.

Here is an update on the most important developments in this area over the past six months.

Accumulators will remain for the foreseeable future

The Centers for Medicare and Medicaid Services (CMS) has cemented the market place for these tactics through the latest Annual Notification and Payment Parameters Rule. Despite strong pressure from the All Copays Count coalition, a consortium of patient advocacy groups and a letter to President Biden signed by several members of Congress from both parties calling for the same, CMS made no changes. Data from TrialCard’s co-payment program, encompassing 99 specialty brand programs in 13 therapy classes, revealed that the total number of patients impacted by the Accumulator increased from 4.5% in 2020 to 8.6% in 2020. 2021. The total number of patients affected by the maximization increased from 2.7% to 4.3% during the same period. Consistent with previous year-over-year trends, combined with a recent study by MMIT indicating that 80% of commercial plans had accumulators available in their benefit design in 2021, with 43% of plan sponsors choosing to have them implemented, an increase from 67% and 39% the previous year and 44% and 28% respectively in 2018, these tactics look set to remain a challenge for patients and manufacturers alike.

Several states have passed or proposed laws prohibiting these practices. However, state anti-accumulator laws are limited in scope only to fully insured plans. Self-funded plans, like most employer-sponsored coverage, are not subject to these laws, as they are governed by the Employees Retirement Income Security Act. In November 2021, Representative Donald McEachin (D-VA) introduced the Help secure a reduction in the patient co-payment law at the federal level. If passed, this law would ban batteries in all plans. As of the date of publication of this article, no action has been taken on this bill.

Manufacturers and providers of co-pay programs are paying close attention to whether these tactics are found in therapies administered by providers and covered by medical benefits. United Healthcare sought to do just that in 2021, but reconsidered in the face of immense supplier 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 pharmaceutical benefit counterparts when it comes to co-pay assistance.

Continued Evolution of Maximizers

Maximizers have grown in popularity with plan sponsors in recent years. They have seen a significant acceleration in 2021, mainly because they allow the plan sponsor to advertise a $0 payout requirement to patients. Another selling point is that, in their most basic form, they avoid the “copay cliff” that plagues patients with traditional accumulators. However, this approach is changing. Manufacturers have recently begun to address the gross-net impact of maximizers by reducing the copayment assistance available once a patient is identified as part of a maximizer plan. In turn, maximizers have become more aggressive in capturing as much of the benefit of the co-pay offer as possible in early claims, to avoid having to absorb the cost for more patients later in the year. . Additionally, SaveOnSP, the Express Scripts-aligned maximization program, has moved from a static copay amount model to a coinsurance percentage design for 2022, mirroring that of PrudentRx.

Manufacturers have also incorporated more explicit program terms and conditions around maximization programs, in a show of intent widely seen as prepositioning to avoid a better impact on future pricing. Certain provisions state that patients identified under the maximization programs will receive a lesser benefit and that the value of the offer may be reduced or canceled at any time. Other terms are so detailed that they state that the health plan agrees that by accepting reimbursement from the program, it will only be credited for patient cost-sharing obligations.

Uncertainty of the best price on several fronts

Problems caused by accumulators and maximizers are likely to worsen in less than a year. From 2023, manufacturers are required to include the value of their co-pay assistance offers in best price calculations, unless they ensure the benefits of the offer are fully provided. to the patient, as required by a CMS Final Rule published in December 2020. publication, manufacturers have been racking their brains collectively in search of solutions that do not result in a more complicated experience and increased financial burden for patients. CMS suggests offering a discount model, whereby patients pay out of pocket and receive direct reimbursement from the program, outside of the pharmacy claim. But given the high expense required, this method will not support many patients. TrialCard met with CMS to discuss operational details of the rule in 2021, but the agency offered little advice. Rather, he maintained the position that manufacturers are responsible for ensuring their programs benefit patients and must 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, just like another co-pay program provider. The uncertain outcome and timing of the trial, however, adds another layer of complication for manufacturers. Changing program design and business processes to be compliant takes months of lead time. Work on these updates must begin soon to be in place by the end of the year, meaning manufacturers won’t have the luxury of waiting for the outcome of the lawsuit to determine whether to modify. program design.

TrialCard continues to follow developments in this area closely. Approach [email protected] to understand how each of these issues will affect your co-pay program and learn more about solution options to ensure compliance and continued patient access and affordability.

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