Bridging the Gap: Speeding Up Medicare Access to Breakthrough Devices

The Urgent Plea for Streamlined Access

A significant alliance of medical technology firms and patient advocacy organizations has collectively appealed to the Centers for Medicare and Medicaid Services (CMS), advocating for a more efficient pathway to secure reimbursement for revolutionary medical devices. This collaborative effort underscores a critical bottleneck in the current healthcare system: the extensive period between a device's approval by the Food and Drug Administration (FDA) and its subsequent coverage by Medicare. Stakeholders are pushing for immediate and substantial reforms to address this persistent challenge.

Unveiling the Coverage Lag

A recent study, cited by the advocating groups, reveals a concerning trend: an average of almost six years elapses from the moment a medical technology receives FDA authorization to when it finally gains Medicare coverage, especially for those innovations requiring new reimbursement mechanisms. This protracted timeline means that patients, who could significantly benefit from these advancements, face undue delays in accessing potentially life-altering treatments and diagnostic tools. The current system’s inefficiencies are highlighted as a barrier to health equity and innovation.

Drawing Inspiration from Past Frameworks

In their detailed proposal to CMS Administrator Dr. Mehmet Oz, the coalition points to elements of the previously withdrawn Medicare Coverage of Innovative Technology (MCIT) framework as a model for future policies. They contend that a program incorporating the fundamental tenets of MCIT could offer a more effective solution than existing protocols. The MCIT model, if reinstated or adapted, would have provided immediate, albeit temporary, national coverage for new breakthrough medical devices or diagnostics upon FDA approval, significantly reducing patient waiting times.

Advocating for Predictability and Timeliness

The proposed approach by AdvaMed and its partners emphasizes the dual benefits of ensuring prompt access for Medicare beneficiaries to FDA-approved devices, while also establishing a clear and predictable roadmap for CMS. This roadmap would guide the agency in gathering necessary evidence for making permanent coverage decisions. Such a system aims to strike a balance between rapid patient access and the meticulous evaluation required for long-term integration into the Medicare system.

Navigating Past Controversies and Future Paths

The MCIT framework, despite its potential benefits, previously faced considerable debate, culminating in its rescission by CMS in 2021. Critics, including certain medical associations, raised concerns regarding the potential unknown safety and efficacy profiles of breakthrough devices within the MCIT population. Despite legislative attempts to codify aspects of the framework, progress has been slow. This lack of legislative advancement has compelled medical technology companies and patient groups to rely on existing initiatives, which they argue are insufficient to meet the demands of truly innovative technologies and the needs of patients requiring immediate access.

Addressing Current Program Deficiencies

The advocating groups contend that existing programs, such as the Transitional Coverage of Emerging Technologies (TCET) program, are inadequate. They describe TCET’s voluntary nature and limited scope as falling short of providing the consistent, timely, and predictable access that breakthrough technologies necessitate. The current mechanisms are seen as failing to deliver life-changing innovations to the patients who stand to gain the most, underscoring the urgent need for comprehensive reform in Medicare's coverage policies for cutting-edge medical devices.