US medical equipment accessibility and Medicare regulation

The United States has introduced new federal mandates to improve medical equipment accessibility for individuals with disabilities. Under the Rehabilitation Act and the Americans with Disabilities Act, the Department of Health and Human Services and the Department of Justice have established requirements for accessible equipment, such as examination tables, weight scales, and X-ray machines, for healthcare providers receiving federal funding.

Simultaneously, the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) introduced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway. This initiative is intended to expedite Medicare coverage for certain FDA Breakthrough Devices, aiming to reduce the timeline from over a year to 60–90 days following FDA approval.

In response to the RAPID proposal, medical organizations and patient advocacy groups have submitted formal comments. The American Association of Neurological Surgeons and the Congress of Neurological Surgeons expressed support for aligning RAPID eligibility with existing FDA programs, while the National Health Council noted the pathway’s potential to reduce delays between market authorization and Medicare coverage.