Solving the Copay and Best Price Challenge

No problem has frustrated biopharma patient support leaders more in the past year than the CMS Final Rule on manufacturer coupons and Best Price. The potential impact of this rule has been the subject of controversy, internal and external assessments, and an ongoing legal challenge. As the January 1, 2023 effective date draws near, industry leaders are facing a decision point in how to prepare their programs for compliance amidst its still uncertain future.

BEGIN WITH THE MATH

The starting point for solution design is understanding a brand’s current Best Price position. This will determine the toolkit of available options. The Medicaid Drug Rebate Program outlines a statutory minimum rebate that all products must offer. Without diving deep into the math (although IntegriChain’s VP of Advisory Services, Jeff Babb, and I will do just that on an upcoming webinar Tuesday March 15 at 1 PM ET – register now!) the important point is that brands with little or no competition may have low or no commercial rebates, requiring them to offer the minimum discount.

These brands may be able to maintain some amount of benefit delivered via the pharmacy copay offer. There are multiple benefits to this model. Keeping access to this claim data allows manufacturers to maintain a detailed level of reporting and conduct the wide range of analysis and patient segmentation activities enabled by it. It also allows for optimal anti-kickback controls that are administered in real time at claim adjudication.

A secondary benefit of this model is that many patients’ cost sharing assistance needs could continue to be supported without disruption. A large portion of patients in any copay program only require a fraction of the available support funds. Patients in accumulator plans would use the pharmacy copay offer up to the benefit maximum. After this, they would be transitioned to a rebate model – more on how that would work in a moment.

The key point in this approach is recognizing that any amount of benefit delivered via the pharmacy copay offer will be conceded as a discount in

Best Price reporting. Patients in accumulator plans will still not receive credit toward their cost sharing obligation, meaning the offer value, albeit reduced, will qualify for inclusion in Best Price calculation. But, since the offer is established to not set a new Best Price for any payer, the impact to Medicaid rebates is minimized.

Brands that are rebating beyond the statutory minimum don’t have this luxury. In these cases, any amount of copay assistance will set a new Best Price if subject to accumulator adjustment. Manufacturers in this position may be forced to forego a traditional copay card in favor of alternative forms of patient reimbursement.

MINIMIZING PATIENT DISRUPTION AND COST OUTLAY

In both scenarios, some patients will require copay assistance delivered outside of the pharmacy claim process. While this approach has drawbacks (Mercalis (formerly TrialCard) ’s public comment letter to CMS on the rule, and its amicus brief supporting the PhRMA lawsuit challenging the rule both explain why) it is a reality of how copay assistance will change if the rule goes into effect.

In a direct reimbursement model, the patient pays their out-of-pocket cost and submits a claim to the copay program to be reimbursed. CMS cites this in the Final Rule as a way for manufacturers to ensure program benefits go only to patients. In a scenario where a brand maintains a lesser value copay offer, patients requiring assistance above that amount would transition to this model. For brands already over the statutory minimum rebate, patients would receive program benefit entirely in this fashion.

Minimizing the time a patient is out of pocket is critical to making this approach work. With the significant cost outlay for specialty therapies, especially for patients in high deductible health plans, waiting for check reimbursement through the mail may not be realistic for many patients.

Solving this challenge was the driving force behind developing TrialCard Pay – Mercalis (formerly TrialCard) ’s full suite of reimbursement capabilities inclusive of electronic direct deposit payments. Patients can upload claims via a mobile-optimized website and select electronic reimbursement via Automated Clearing House (ACH) or the Zelle network. Reimbursement funds are then deposited in the patient’s bank account within days.

Incorporating this capability in program design achieves Best Price compliance and reduces the negative gross-to-net impact of copay accumulators. With accumulators poised to remain a part of the benefit design landscape, TrialCard Pay arms life science companies with a means to accelerate the impact of their copay assistance programs and ensure that the dollars allocated go to the intended recipients – patients.