Update: On October 17, 2023, the U.S. District Court for the District of Columbia struck down the provision in the Patient Protection and Affordable Care Act 2021 Notice of Benefit and Payment Parameters final rule that allowed health insurers to not count drug manufacturer copay assistance towards a beneficiary’s out-of-pocket costs. The Department of Health and Human Services (HHS) appealed the court's ruling, but on January 17, 2023 HHS dropped the appeal. As a result, the 2020 rule on cost-sharing is in full effect, which requires insurers to count copay assistance towards patient cost-sharing.
On May 7, the Centers for Medicare & Medicaid Services (CMS) released the Patient Protection and Affordable Care Act 2021 Notice of Benefit and Payment Parameters final rule, which updates the regulatory and financial standards for Affordable Care Act (ACA) Exchanges. The rule finalized a policy that gives insurers the discretion to not count any form of direct support from drug manufacturers to enrollees for specific prescription drugs toward the annual limit on patient cost sharing amounts.
The Association for Clinical Oncology (ASCO) previously expressed concerns that the exclusion of drug manufacturer coupons from the annual limitation on beneficiary cost sharing and the automatic re-enrollment without advanced premium tax credits (APTCs) could erode access to affordable care for people with cancer, and the Association urged CMS not to finalize these proposals.
In ASCO’s view, such a policy could remove a safety net for patients who need expensive specialty medications but cannot afford them, leading to poorer health outcomes and potentially higher costs to the health care system. ASCO also has concerns that additional complexity in health care coverage policy will increase the administrative burden on oncology practice staff, who will need to understand the nuances across multiple insurance plans and then explain to patients why some of their financial assistance is not helping them reach their deductible.
ASCO, in its comments on the prosed rule, successfully advocated against CMS’ proposal to automatically reenroll beneficiaries with $0 coverage premiums without the APTCs to which they are entitled. The Association stated that such a change could create confusion for beneficiaries who have previously been automatically reenrolled in their $0 premium plan and could lead these individuals to lose their coverage by failing to recertify their need for assistance. CMS agreed with ASCO’s position, and the Association applauds the agency’s decision not to adopt the proposal.
ASCO will continue to weigh in on such issues and support policies aimed at improving the affordability of and access to specialty cancer drugs. ASCO’s policy brief on co-pay accumulators has additional information.
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