Rick and Jason outline their view of the crucial issues in the new proposed rule from Centers for Medicare and Medicaid Services (CMS) regarding copay accumulator adjustment programs. They preview the public comments that TrialCard expects to submit to CMS.
Please visit TrialCard’s copay accumulator program resources to learn more about mitigating copay accumulator programs. Contact sales@trialcard.com to discuss solutions for your organisation.
Read on for Rick’s and Jason’s insights.
CMS Best Price Proposal and Copay Assistance: How New Rule Could Change the Access Landscape
By: Rick Fry, Senior Vice President, Commercial Solutions, TrialCard and
Jason Zemcik, Senior Director, Product Management, TrialCard
Current regulations around best price determination allow for manufacturer assistance offers to be excluded “to the extent that the program benefits are provided entirely to the patient and the pharmacy, agent, or other entity does not receive any price concession.”
With the advent of copay accumulator and maximizer programs in recent years, the full value of copay assistance is not always applied to the benefit of the patient. Pharmacy Benefit Managers (PBMs) and health plan sponsors take advantage of these funds to reduce their cost burden for many drugs.
The Proposed Rule places responsibility on pharmaceutical manufacturers to ensure that copay assistance benefits are provided entirely to the patient to maintain exclusion from best price determination. CMS states, “We believe manufacturers have the ability to establish coverage criteria around their manufacturer assistance programs to ensure the benefit goes exclusively to the consumer or patient.”
CMS announced a 30-day public comment period on this proposal, which ends July 20, 2020. TrialCard will be submitting comments to CMS and are encouraging our manufacturer partners and patient advocacy groups to do the same. The sections below outline issues that make the Proposed Rule problematic and ill-advised.
THERE IS NO REASONABLE METHOD FOR MANUFACTURERS TO ENSURE THE BENEFIT OF ASSISTANCE PROGRAMS GOES EXCLUSIVELY TO CONSUMERS.
Placing responsibility on pharmaceutical manufacturers to ensure that the benefit of copay assistance goes only to patients is an unrealistic standard.
Determination of how manufacturer support funds are accounted for is made by the health plan sponsor, fully independent of the pharmaceutical manufacturer. In nearly all cases, the manufacturer is unaware of whether the patient’s health plan has an accumulator adjustment policy in place. Many health plans do not openly publish their policy on accounting for manufacturer support funds.
In addition, self-funded plan sponsors have significant flexibility to change benefit designs as they choose. A plan could implement an accumulator adjustment policy at any time within the plan year. The same patient in the same manufacturer program could receive the full benefit of the copay support offer on one use, but not on a subsequent use, entirely outside of the control of the manufacturer.
A more reasonable standard would be to require manufacturers to have appropriate safeguards in place to enable only patients to benefit from their copay support programs. TrialCard has worked with several pharmaceutical manufacturers to design program rules that are compliant with applicable regulatory requirements. This same approach could be applied to meet a reasonable standard of responsibility on this issue.
THIS REVISION COULD RESTRICT PHARMACEUTICAL MANUFACTURERS’ ABILITY TO OFFER PATIENT ASSISTANCE FOR MANY SPECIALTY DRUGS, WHICH WOULD RESULT IN NEGATIVE HEALTH OUTCOMES WHILE ALSO NOT ACHIEVING THE DESIRED IMPACT ON BEST PRICE.
Many copay assistance programs could become financially untenable for manufacturers if they were required to include the full value of their offer in best price calculations. This would be gravely detrimental for patients taking specialty therapies without generic alternatives. Many such patients are battling serious conditions and rely on copayment support to afford life-sustaining medications.
CMS noted in the 2021 Notice of Benefit and Payment Parameters that copay accumulator adjustments are an effective way for health plans to address the rising cost of prescription drugs by steering patients toward more cost-effective generic options. However, for specialty therapies without generic alternatives, this is not an option. While on the surface it may seem that rising drug costs are to blame for this problem, multiple studies show this is not the case. Net drug prices, inclusive of manufacturer rebates to PBMs, have remained relatively steady or, in some cases, decreased in recent years.
Discontinuation of copay assistance programs would also produce a situation that runs counter to CMS’ intent. The absence of a manufacturer offer would mean that the resultant impact on best price would not be achieved, leaving several patients without much-needed support while making no positive progress toward achieving a lower price for Medicaid programs.
This Proposed Rule is sure to generate significant discussion on both sides of the issue. How CMS will ultimately resolve these conflicts remains to be seen, although it is imperative that any resolution be guided by a primary goal of making access to necessary therapies attainable for patients.
TrialCard is prepared to offer alternatives to manufacturers to ensure that patients can afford specialty therapies, regardless of whether (and to what extent) the Proposed Rule is adopted. For more information about copay accumulator programs, please visit TrialCard’s copay accumulator program resources. To speak to one of our team members, please contact us at sales@trialcard.com.
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