US accelerates Medicare access for select medical devices

US health authorities have announced a new program aimed at significantly reducing the time required for certain medical devices to secure Medicare reimbursement. Coverage could now be granted within two to three months of regulatory approval, down from a year or more previously. This reform addresses long-standing industry criticism regarding the penalizing lag between FDA validation and Medicare coverage.

The program, dubbed RAPID, establishes enhanced coordination between the Food and Drug Administration and the Centers for Medicare & Medicaid Services for devices designated as "breakthrough," particularly Class II and Class III products. A national coverage determination may be proposed as soon as the product is authorized, followed by a 30-day public comment period. Approximately 40 devices are expected to be eligible initially, including heart valves, arrhythmia treatments and stimulation implants.

Authorities are highlighting a more transparent and predictable process for manufacturers, featuring clarified eligibility criteria. This shift is viewed as a boost for innovation and could bolster the attractiveness of the US market. It meets the expectations of major industry players, such as Medtronic and Johnson & Johnson, while facilitating patient access to advanced medical technologies.