On August 26, 2019, the Departments of Health and Human Services (HHS), Labor, and the Treasury (collectively, the Departments) jointly announced that they will not enforce HHS’s recently finalized policy that limits private health plans’ use of accumulator programs — i.e., programs that exclude the value of direct manufacturer cost-sharing support (such as co-pay coupons) from patients’ annual cost-sharing limits — to prescription brand drugs for which a medically appropriate generic equivalent is available.
The Departments concluded that the policy conflicts with existing Internal Revenue Service (IRS) guidance that requires high-deductible health plans (HDHPs) to exclude all drug and manufacturer discounts when calculating patient contributions toward plan deductibles. The Departments will address this conflict by permitting health plans to use accumulator programs and exclude the value of manufacturer coupons from annual cost-sharing limits — regardless of whether medically appropriate generic equivalents are available — until a revised policy is issued for the 2021 plan year.
The Departments acknowledged in their August 26 guidance that stakeholders expressed concern that HHS’s accumulator policy may conflict with IRS guidance on HDHPs in circumstances where a generic equivalent is not available or medically appropriate. Under existing IRS guidance, HDHPs are required to disregard drug discounts, including manufacturers’ discounts, in determining whether the minimum deductible for a HDHP has been satisfied. The Departments stated that, without further clarification, HDHP issuers and sponsors may not be able to simultaneously comply with both the IRS requirement and HHS’s accumulator policy when a generic equivalent is not available or medically appropriate.
To address the conflict, the Departments will permit plans and issuers to exclude the value of manufacturers’ coupons from annual cost-sharing limits regardless of whether medically appropriate generic equivalents are available. States will be permitted to adopt a similar enforcement policy. HHS, in consultation with the Departments of Labor and the Treasury, intends to issue new regulations in the forthcoming NBPP for 2021. Until revised rules are issued and effective, however, the Departments will not initiate enforcement actions if issuers or plans exclude the value of coupons from annual cost-sharing limits, including in circumstances where no medically appropriate therapeutic generic equivalent is available.
The guidance, which is not limited to HDHPs, notably expands the scope of HHS’s accumulator policy for the 2020 plan year. In addition to monitoring developments regarding coupons, accumulator programs and patient access in light of this guidance, stakeholders should remain alert to any changes in state enforcement policies and consider opportunities to engage with the administration on revisions to the accumulator policy as part of the NBPP rulemaking for 2021.
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