Last week, the Centers for Medicare and Medicaid Services (CMS) released the final 2021 Notice of Benefit and Payment Parameters (NBPP) rule. The complete rule is 350 pages and covers a variety of topics, including one that has been of particular interest to pharmaceutical manufacturers in recent years—co-pay accumulators.
This post will provide a high-level overview of what the provisions in the 2021 NBPP mean for co-pay programs going forward.
Plan sponsors can, but are not required to, operate accumulator adjustments programs in 2021.
CMS speaks throughout the NBPP to its desire to afford plan sponsors maximum flexibility in determining whether they wish to count forms of direct manufacturer support, such as coupons (co-pay cards) toward patients’ cost-sharing obligations. The document mentions that direct manufacturer support, such as coupon programs, can cause market distortion by leading patients to choose higher-priced brand name drugs over less costly generics. Allowing plans to implement accumulator adjustment programs is a means by which plan sponsors can address this issue, CMS contends.
Accumulator adjustments are permitted regardless of whether or not a drug has an available generic equivalent.
Generic availability has consistently been one of the main contention points on the accumulator issue. Many patient advocacy groups make the case that for high-cost specialty medications still within their exclusivity period where there is no generic available, allowing plans to deny patients credit for cost-sharing support from manufacturers is unfair. CMS acknowledged such feedback received during the rule’s comment process but ultimately chose the flexibility route, leaving the decision to plan sponsors even if patients have no generic option to choose.
State laws prohibiting accumulator adjustments take precedence over the NBPP rule.
As of April 2020, four states (Arizona, Virginia, West Virginia, and Illinois) have passed legislation prohibiting plans from operating accumulator adjustments. Several other states have similar proposed legislation up for consideration. CMS notes in the NBPP that the permission to exclude direct manufacturer support from patients’ cost-sharing responsibility is allowable “to the extent consistent with applicable state law.”
State anti-accumulator laws don’t apply to all plans.
In most cases, state laws prohibiting accumulator adjustments apply to only fully-insured plans regulated by the state insurance commission. Approximately 61% of workers are in a self-funded plan (employer-sponsored coverage where an employer pays its employees’ claims), according to the 2019 Kaiser Family Foundation Employer Health Benefits Survey. While state-level legislation can somewhat decrease the negative impact of accumulator adjustments on co-pay program effectiveness, it is not a catch-all solution.
So what does it all mean going forward?
The main takeaway from the 2021 NPBB is that co-pay accumulators are likely to remain an area of concern for pharmaceutical manufacturers for the foreseeable future. By giving plan sponsors significant latitude, the rule positions accumulator adjustments as an attractive cost-saving measure.
It’s important to understand how the provisions of the rule impact your program and patient population based on all of the applicable factors such as offer design, therapeutic class, and patient demographic. TrialCard regularly conducts accumulator impact analysis for manufacturers to examine exactly how their programs are being affected and guide appropriate mitigation strategies.