Copay Accumulators Can Stay, COVID-19 and Other Rx Roundup

In May of 2020, the Centers for Medicare and Medicaid Services (CMS) issued final regulations confirming that group health plans can exclude drug manufacturer coupons from out-of-pocket limits such as deductibles.

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Copay Accumulators Can Stay

In May of 2020, the Centers for Medicare and Medicaid Services (CMS) issued final regulations confirming that group health plans can exclude drug manufacturer coupons from out-of-pocket limits such as deductibles.

In 2019, CMS regulations created some confusion as to whether group health plans could continue excluding prescription drug coupons from deductibles when there was no generic equivalent available. A subsequent FAQ offered temporary relief, providing that group health plans with copay accumulators in place would not need to change accumulator features—at least with respect to deductibles and other out-of-pocket costs—through the 2020 plan year. The Business Group, along with other stakeholder organizations, engaged with CMS, the Department of Labor, and other regulatory entities to discuss the role copay accumulators play in controlling prescription drug costs and complying with IRS rules for HSAs and high-deductible health plans.

The welcome result is final regulations clarifying that for the 2021 plan year and onward, group plans and health insurance issuers have discretion to determine whether to include or exclude coupons from cost sharing (such as deductibles), regardless of whether a generic equivalent is available.

CMS also encourages group health plans to:

  • Be transparent with plan participants about whether drug manufacturer coupons apply to out-of-pocket limits; and
  • Prominently include this information on websites and in brochures, plan summary documents, and other materials that participants may use to select, plan, and understand their benefits.

COVID-19 Prescription Drug Round-Up with Potential Future Policy Implications

  • Potential treatment shows more promise. The experimental drug Remdesivir improved symptoms when given for five days to moderately ill, hospitalized patients with COVID-19, according to both the Associated Press and Reuters.
  • Continuation of hydroxychloroquine trial. After announcing temporary suspension of the trial in May 2020, on June 3, the World Health Organization announced it would restart its trial of hydroxychloroquine after getting the all-clear from a safety review.
  • Refocus on drug pricing. President Trump told Republican senators during a closed-door lunch on Capitol Hill that he still wants congressional action to lower drug prices, even though the coronavirus pandemic has become a priority, according to comments by Sen. Chuck Grassley (R-Iowa).
  • Increased oversight of antibody tests. The U.S. Food and Drug Administration tightened its oversight of antibody tests for COVID-19 earlier last month and began publicly listing commercial manufacturers that have either failed to submit an emergency use authorization request or voluntarily withdrew notification for their antibody tests distributed under the previous agency policy, Regulatory Focus notes. The move follows reports questioning the accuracy of some of the antibody tests on the market.
  • COVID diagnostics and medications collaboration. The FDA has entered into an agreement with Aetion to collaborate on advanced analytical techniques to answer urgent coronavirus disease (COVID-19) research questions. Specifically, the collaboration aims to answer questions about the use of diagnostics and medications in the pandemic and risk factors for COVID-19-related complications in different patient populations.
  • Addressing supply chain challenges. In May of 2020, the FDA issued guidance to provide a policy to help address current manufacturing limitations or supply chain issues due to disruptions caused by the COVID-19 public health emergency.

If you have questions, comments, or concerns about these or other regulatory and compliance issues, please contact us.

We provide this material for informational purposes only; it is not a substitute for legal advice.

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