Thanks to recent regulatory moves as well as the increasing prevalence of copay accumulator/maximizer programs, the tactics that payers use to counter drug manufacturer copay assistance continue to be a controversial topic in the health care sector. However, it’s still unclear how the Biden administration will approach the issue, industry experts say, so stakeholders on both sides of the debate should prepare for more uncertainty.
Copay accumulators work by preventing any monetary assistance that pharmaceutical companies offer commercially insured patients from counting toward their deductible or out-of-pocket maximum. Their close cousin, copay maximizers, take the total amount of a manufacturer’s copay offset program and divide it by 12, and that amount becomes the new monthly copayment for all patients on any given drug over the course of a year.
From insurers’ perspective, the goal of copay accumulators/maximizers is to help steer patients toward lower-cost drugs. As America’s Health Insurance Plans has stated in a March 2020 comment letter to CMS: “Branded manufacturers offer coupons to circumvent patients’ cost-sharing for branded drugs and to avoid responsibility for the fundamental reason for higher patient costs — namely, the high price of the drug that is set and controlled solely by manufacturers.”
When asked whether payers have a point about the effect of copay coupons, Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates, tells AIS Health that “there is some evidence that the answer is a qualified ‘yes.’”
He points to a study conducted by the Massachusetts Health Policy Commission in 2020, which examined 14 branded drugs and found that “coupon availability is associated with moderately higher utilization of branded drugs relative to use of generic close therapeutic substitutes, and that coupon availability is associated with higher total spending.” The study did note, however, that “it is unclear if results from the 14 cases are representative of all couponed drugs with generic close therapeutic substitutes.”
Copay accumulator programs have been fiercely criticized by the pharmaceutical industry and patient advocates, who argue that they lead to higher costs for consumers and limit access to life-saving medications. As a report published this month by The AIDS Institute argued: “These policies contribute to insurance company profit while shifting the cost of expensive prescription drugs back to the patients who most rely on them, and they have become more common in recent years.”
To prove the latter point, The AIDS Institute reviewed plans offered on the Affordable Care Act exchanges in 2021 and found that in 32 states, at least two-thirds of exchange plans included a copay accumulator program (see infographic, p. 4.) In 14 states, the report said, every plan on the exchange includes a copay accumulator, although five states have laws that prohibit such policies in fully insured plans.
Programs Are Seeing Broader Adoption
Meanwhile, data collected by AIS Health’s parent company, MMIT, show that copay accumulators and maximizers are gaining steam across the commercial insurance space. Of insurers covering a collective 127.5 million lives, 41% had implemented a copay accumulator program and 32% had implemented a copay maximizer program prior to 2020, and another 26% and 24%, respectively, implemented such programs in 2020.
Recent revisions to federal regulations may be contributing to the increasing prevalence of copay accumulators. In its Notice of Benefit and Payment Parameters (NBPP) for 2021, which was finalized in June, CMS allowed non-grandfathered group and individual market plans to use copay accumulator policies — including in cases where a branded drug does not have a generic equivalent. That was a reversal from the proposed rule, which allowed such policies only when generic alternatives are available.
“While the use of copay accumulators and maximizers has typically occurred in the self-insured markets, the most recent NBPP changes may lead to a broader adoption of these copay adjustment programs in other markets and introduce risks to manufacturer assistance program spend and patient out-of-pocket liability,” suggested a Feb. 23 analysis from Avalere Health.
That report also pointed to a December 2020 rule aimed at facilitating value-based contracts for prescription drugs in Medicaid managed care, which “created new risks for manufacturers when copay accumulator or maximizers are applied to their products.” Avalere explained that starting in 2023, drugmakers must ensure that the full value of copay assistance is passed onto patients, or those dollars will effectively lower the average manufacturer price and best price as part of the Medicaid Drug Rebate Program.
“They’ve definitely introduced new uncertainties and complexities into the market,” Mark Gooding, a principal at Avalere and co-author of the report, says of the regulatory developments related to copay accumulators. “The expectation is that the NBPP would allow for broader use of these programs,” he says, while the Medicaid rule “creates a new pressure for manufacturers to really identify solutions or other methods to address these accumulators.”
Both regulations were finalized under the Trump administration, and could be revised by the Biden administration. According to Gooding, it’s not yet obvious what stance the administration will take. “We are still getting a sense of how new leadership at HHS and CMS view the role of accumulators and the risk that they pose to patient access and affordability,” he says.
On a more local level, he adds, “Oklahoma and Kentucky are two examples of where state legislatures are looking to create limits on how these accumulators and maximizers can be implemented.”