On May 17, 2022, the U.S. District Court for DC ruled against the “Accumulator Adjustment Rule,” which would require that pharmaceutical companies ensure the full value of any financial assistance is passed to the patient. This decision sided with PhRMA (Pharmaceutical Research and Manufacturers of America), who challenged the Health and Human Services on the proposed ruling.
In this blog, we will review how this ruling was proposed, what the outcome means for pharma, and what pharma can learn from the ruling to best position themselves for the future.
Background on the Accumulator Adjustment Rule
The proposed Accumulator Adjustment Rule would have imposed new regulatory requirements on manufacturers. Specifically, it would have placed the burden on manufacturers to “ensure the full value of the assistance or benefit is passed on to the consumer or patient”. This means that other stakeholders (payers, PBMs, employers) could not take advantage of the pharma benefit dollars intended to help the patient. In addition, this proposed rule would have made it so that patient assistance cannot be excluded from Best Price, which states that Medicaid patients are offered the net lowest price of a drug.
In theory, pharma companies would prefer that all their benefit dollars transfer to their patients, instead of the payer. That is the fundamental purpose of patient access programs. Therefore, at face value, this proposed Accumulator Adjustment Rule seems like one that pharma would support. However, the primary concern with the proposed rule was that pharma isn’t able to see if their brand’s patient access offering abide by the Medicaid Best Price rule. This rule requires that Medicaid patients receive the lowest price for a drug.
Here is where the problem with this proposed law arises. If a medication is included in an accumulator, the payer of that program is not required to divulge how much of the pharma’s benefit spend is going towards the patient (versus being captured by the PBM or accumulator provider). Because of this, there is no way for the pharma manufacturer to ensure that their Medicaid patients are getting the “best” or lowest price for their medication. Due to this lack of transparency, PhRMA formally challenged the ruling in May 2021.
The U.S. District Court recognized this impediment for pharma manufacturers and therefore ruled against the proposed accumulator adjustment requirement. Generally, pharma companies were relieved at this ruling, as they can now continue offering patient assistance without fear of violating the Medicaid Best Price rule.
But what can we learn from this hearing? While this suit didn’t change the way accumulator programs are run, it’s important to reflect on how we got here in the first place. Accumulator programs are here to stay, and pharma manufacturers need to understand how to best structure their patient access strategies with, or around, accumulators and/or maximizer programs.
The problem with the lack of transparency into accumulator programs
The Accumulator Adjustment Ruling brought to light just how difficult it is for pharma brands and the broader pharmacy market to understand exactly how brands are being priced on accumulator programs, or whether they are being included in accumulator programs at all. This lack of visibility makes it incredibly difficult for pharma manufacturers to build optimized patient access programs.
The pharmacy market did its best to prepare for the Accumulator Adjustment 2023 rule. Brands took their best educated guess at Best Price, but they still couldn’t guarantee that Medicaid patients were always getting the lowest price 100% of the time. To solve for this, copay and patient access vendors introduced potential solutions, including a debit card system, whereby the pharma brand would directly send patients pre-loaded debit cards to use on their branded drug fills.
In 2022, the market was not quite ready for the Accumulator Adjustment Rule to be put into practice, but brands need to begin to strategize about how to build patient access programs around accumulator programs.
Preparing for a brighter future with accumulators
Brands need to be proactive about building innovative patient access programs that solve for the lack of transparency from accumulator programs. Many patient access providers continue to create new solutions that band-aid the access problems created by PBMs and payers, costing pharma an increasing amount of money.
What if there was an opportunity to break this mold? By thinking out of the box, pharma can optimize for the best possible net price, avoid the lack of transparency caused by accumulator programs, and prevent limitations with formulary tiering. This would require the current pharmacy ecosystem to reimagine its current worldview of patient access. Instead of accepting the inevitable fate of prior authorizations, Hubs, and automatic buy-down, brands can build patient access programs independent of the PBMs.