Mercalis (formerly TrialCard) Submits Comments Opposing CMS Best Price Proposed Rule

Mercalis (formerly TrialCard) has submitted comments to the Centers for Medicare and Medicaid Services (CMS) on the proposed rule, CMS-2482-P—Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements.

A provision of this proposed rule requires pharmaceutical manufacturers to include the value of vouchers and coupons they offer as patient cost-sharing assistance in their calculation of best price, in scenarios where the manufacture cannot ensure that the benefit of the offer goes entirely to patients. This proposal is particularly problematic due to a growing number of health plans operating co-pay accumulator adjustments, under which the value of manufacturer support offers is not counted toward a patient’s deductible.

Mercalis (formerly TrialCard) strongly opposes this aspect of the proposed rule. In our comment letter to CMS, we expressed the following critical issues it raises and why it should be withdrawn from consideration:

The proposal would impose a new standard that is impossible for manufacturers to meet and that, if finalized, could create a situation where assistance programs cannot feasibly be continued, resulting in patients being unable to afford and therefore losing access to important medications.

Neither patients nor pharmaceutical manufactures has control over whether or in what situations a health plan or pharmacy benefit manager may apply an accumulator adjustment, or whether the payer chooses to be forthright about whether it has such a program in place or how it operates. Accordingly, it is simply not possible for a manufacturer to ensure that the co-pay assistance provided is passed entirely to the patient, even though it’s the manufacturer’s intent.

The proposal is an inappropriate mechanism for addressing the issues caused by accumulator adjustments that CMS identifies in the proposed rule and, if finalized, would result in significant harm to patients and lead to negative health outcomes.

CMS acknowledges in the proposed rule that accumulator programs generate savings for health plans at the expense of—and often to the surprise of—patients. Yet, instead of seeking to reduce the harm inflicted by accumulator programs through transparency requirements imposed on plans and PBMs or through limits on the application of accumulator programs (as a number of states have enacted legislation to address), the proposed rule instead takes aim at the assistance programs that are designed and intended to facilitate access and affordability for patients.

The proposal is even more troubling in light of the ongoing COVID-19 pandemic.

COVID-19 continues to exacerbate access barriers and financial hardships for individuals across the country, especially those with serious and chronic health conditions. Because of this, it is simply not an appropriate time to implement ill-considered and untested policies that cut off critical resources and restrict access avenues for patients.

For these reasons, we have strongly urged CMS to withdraw this proposal. The full text of our comments can be found here: Comments to CMS–2482–P (TrialCard 07.20.2020).