In a recent ruling in the DC Circuit, the Court struck down a Trump-era rule (adopted by the Biden Administration) that prevented patients from using copayment cards and coupons towards any yearly deductibles. For those who may not fully understand the pharmacy space, patients typically have cost-sharing (not unlike traditional healthcare) associated with prescription medications.
In a 2021 rule, HHS put forth guidance that the use of what were known as accumulators or maximizers were not to be part of the deductible metric. Generally, Pharmacy Benefit Managers (PBM) and health plans are not fans of copay assistance programs, such as coupons and such, as they force a patient to have the name brand of the drug, which is obviously much more costly than the generic version of the drug. You can find that these programs exist with some of the high-dollar medications out there, and if there is a generic alternative, the costs remain high since name brands are higher in reimbursements than the generic equivalent.
Certain drugs are put into the accumulator category by the PBM or the health plan. As such, they are readily identified as drugs where any manufacturer-based cost-sharing is not applicable to the plan deductibles, thus triggering the additional financial burden of the deductible to the patient. PBMs and plans know that a cost assistance program is being used, as it is treated as a secondary insurance to the primary payer. In striking the rule, the Court indicated that these assistance programs should count towards the deductible. The interesting part of this is that this rule has no effect on Medicare and Medicaid, as it has been previously determined that the use of such programs is considered a kickback under federal law. The HHS rule, however, was directed towards small group plans sold through the Marketplace, as well as a few other categories. States, however, have had some restrictions on limits for copay assistance previous to the HHS ruling. Why is this a thing?
From a patient-centered perspective, those who potentially have high out-of-pocket deductibles and cost-sharing can see those amounts greatly reduced, particularly for HIV and other specialty drugs. Since the cost-sharing will be provided by the manufacturer, the patient will quickly hit their plan deductible for drugs, and their individual financial exposure will be reduced. But as with all things, there are negatives. At least from the first blush, the ability to force a patient or prescriber to accept a generic to reduce costs is potentially gone (while the coupon may have been a positive for the cost of the medication, not having that cost be applied to a deductible, continued to provide a large financial burden). There is now no incentive for a patient to want a generic, particularly in an environment where the patient has the potential of a $0 copayment due to the coupon or other cost-sharing assistance. As such, the potential to lower healthcare costs is gone.
I suspect that this ruling will be appealed by HHS. The advocacy groups that filed in the DC Court are clearly happy with the result, thus far, as the drugs that were the center of the controversy are high-dollar medications and patients taking them likely have large out-of-pocket expenses from their overall medical care.