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18 September 2019
On 26 August 2019 the Department of Health and Human Services (HHS), the Department of Labour and the Treasury jointly announced that they will not enforce the HHS's recently finalised policy that limits private health plans' use of accumulator programmes – that is, programmes which exclude the value of direct manufacturer cost-sharing support (eg, 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 towards plan deductibles. The departments will address this conflict by permitting health plans to use accumulator programmes 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.
In April 2019 the HHS issued the final Notice of Benefit and Payment Parameters (NBPP) for 2020, which, among other policies, permits health plans and health insurance issuers to exclude the value of drug manufacturers' co-pay coupons from patients' annual cost-sharing limits in certain circumstances. More specifically, the policy – effective for plan years beginning on or after 1 January 2020 – permits the use of accumulator programmes for prescription brand drugs with available and medically appropriate generic equivalents. As clarified in the guidance's preamble, the policy prohibits accumulator programmes and requires plans and issuers to include the value of manufacturer co-pay coupons for purposes of a patient's annual cost-sharing limit if a generic equivalent is not available or medically appropriate.
In their 26 August 2019 guidance, the departments acknowledged that stakeholders expressed concern that the HHS's accumulator policy may conflict with the IRS guidance on HDHPs in circumstances where a generic equivalent is not available or medically appropriate. Under the existing IRS guidance, HDHPs must disregard drug discounts, including manufacturers' discounts, in determining whether the minimum deductible for a HDHP has been satisfied. The departments have stated that, without further clarification, HDHP issuers and sponsors may not be able to simultaneously comply with both the IRS requirement and the 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. The HHS – in consultation with the Department of Labour and the Treasury – intends to issue new regulations in the forthcoming NBPP for 2021. However, until the revised rules are issued and effective, 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 the HHS's accumulator policy for the 2020 plan year. In addition to monitoring developments regarding coupons, accumulator programmes 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.
For further information on this topic please contact Meenakshi Datta, Donielle McCutcheon, Kat Makielski or Corbin T Santo at Sidley Austin by telephone (+1 312 853 7000) or email (firstname.lastname@example.org, email@example.com, firstname.lastname@example.org or email@example.com). The Sidley Austin website can be accessed at www.sidley.com.
Catherine Y Starks, associate, assisted in the preparation of this article.
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