Featured Expert Contributor—Life Sciences and Medtech Regulation
Matt Wetzel is a partner, and Heath Ingram is an associate, with Goodwin Procter LLP. Prior to joining Goodwin, Matt served as Chief Compliance Officer of a Silicon Valley biotech start-up and was the Vice President & Deputy General Counsel of the world’s largest medical technology trade association in Washington, DC, AdvaMed. Originally appeared on the firm’s Life Sciences Perspectives blog.
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Under typical prescription drug insurance programs, patients are obligated to pay a deductible and cost-sharing (i.e. a copay) throughout the plan year, up to an out-of-pocket spend cap. Once the patient hits that spend cap, the insurance company is responsible for the patient’s prescription drug costs.
Under an accumulator program, on the other hand, an insurance company does not count a manufacturer’s copay support (for example, a copay card that a patient presents at a pharmacy to cover the cost of the copay) towards a patient’s annual deductible or out-of-pocket maximum. By excluding manufacturer copay support and coupons from patients’ cost-sharing cap, this means that, even after a manufacturer’s copay support is exhausted for the year, patients remain on the hook for all cost sharing obligations up to the insurance plan’s out of pocket maximums. Many states have implemented laws to ban copay accumulator programs, asserting that such programs actually increase the financial burden on patients, especially with respect to specialty or more expensive drugs. As of June 2023, 19 states have implemented copay accumulator program bans.
HIV and Hepatitis Policy Institute et al v. HHS was brought by patient advocacy groups including the HIV and Hepatitis Policy Institute and the Diabetes Patient Advocacy Coalition, among others, who challenged a May 2020 rule from HHS, the “Notice of Benefit and Payment Parameters for 2021” (85 Fed. Reg. 29164, 29230-35, 29261 (May 14, 2020)) (the “2021 NBPP”) that permitted insurers to impose accumulator polices. Plaintiffs opposed the accumulator program, asserting that manufacturer copay support should count towards calculating patients’ cost sharing obligations and should not be excluded from such calculations.
In ruling in favor of the plaintiffs on their motion for summary judgment, the U.S. District Court set aside the 2021 NBPP, largely supporting plaintiffs’ challenges that the 2021 NBPP rule’s language is internally contradictory, that it runs counter to the statutory definition of “cost sharing” found in the Affordable Care Act, and that it runs counter to the agencies’ pre-existing regulatory definition of “cost sharing.” HHS had previously defined “cost sharing” in a 2012 regulation as “any expenditure required by or on behalf of an enrollee with respect to essential health benefits,” which by its terms includes “deductibles, coinsurance, copayments, or similar charges, but excludes premiums, balance billing amounts for non-network providers, and spending for non-covered services.” See 45 C.F.R. 155.20. In other words, the regulation treats cost sharing is an “expenditure” by or on behalf of a plan enrollee. According to plaintiffs, and as affirmed by the court, this includes manufacturer copay assistance support.
The court disagreed with the government’s technical arguments regarding the language of the 2021 NBPP (i.e. that manufacturer copay support is actually a “reduction” in the amount the patient owes towards cost sharing or a reduction in the “actual economic impact” on the drug manufacturer and not an “expenditure”), concluding that the 2012 regulation was likely intended to define “cost sharing” as costs that are (1) required of an insurance plan enrollee and (2) paid by or on behalf of that enrollee – including manufacturer copay coupons and assistance.
It is unclear if the ruling will be appealed; however, as a result of the District Court’s ruling, the government will use an earlier 2020 version of the rule which allowed insurers to exclude from cost-sharing caps only copay support coupons for branded drugs that have available generic equivalents; if there is no generic equivalent, under the 2020 version of the rule, manufacturer copay support must be counted toward cost sharing.
The U.S. District Court ruling is a significant development for drug manufacturers who offer copay support as a means of providing relief to patients with respect to cost-sharing requirements under their insurance coverage as opposed to offering significant rebates, discounts, or other contracting strategies. However, manufacturers of branded drugs with a generic equivalent will still need to consider how copay accumulator programs could affect access in those states that have not yet banned the practice. Notably, in the wake of this ruling, patient advocacy organizations have indicated that they will continue to advocate for a comprehensive state and federal level ban on copay accumulator programs (e.g. Immune Deficiency Foundation).