After advances and setbacks, policy makers have revived efforts to improve the Medicare coverage process for new medical devices. Industry groups and others have long argued that the existing process is inefficient and unpredictable, and that a streamlined pathway for coverage decision making is needed for novel technologies that address serious and life-threatening illness. However, more rapid coverage processes, with shorter review periods and greater reliance on intermediate or surrogate endpoints, often mean more uncertainty about a technology’s risks and benefits at the time of coverage. The enduring challenge is how to expedite the process to ensure that Medicare beneficiaries have appropriate, timely access to novel medical technologies, while providing robust and efficient mechanisms for evidence generation in the pre- and post-coverage period.
In January 2021, the Trump administration issued a rule, Medicare Coverage of Innovative Technology (MCIT), that would have conferred automatic coverage for medical devices that the Food and Drug Administration (FDA) granted “breakthrough” status and approved or cleared for use. The breakthrough designation is intended for devices addressing unmet needs and for which existing treatment options are inadequate. The Biden administration initially delayed MCIT’s implementation to allow for further review and then rescinded the regulation in November 2021.
Congressional and administration officials have continued to work on the issue. The Centers for Medicare and Medicaid Services (CMS) has held listening sessions with stakeholders, and a modified version of the rule termed Transitional Coverage for Emerging Technologies (TCET), is expected later this year or in early 2023. Congress is working on potential legislation, including one option to resurrect elements of MCIT and incorporate it into the Cures 2.0 Act. Interested groups have held webinars and workshops and issued white papers to inform the discussion. In this Forefront article, we examine the debate over TCET and offer options for consideration, with particular attention to how Medicare might operationalize proposed changes. This article is adapted from a more detailed white paper that is available on the Tufts-CEVR website.