Quartz
Subscribe
Quartz
Subscribe
Edition
Business News
A.I.
Technology
Money & Markets
Leadership
Lifestyle
Latest

Get Quartz in your inbox

Free daily briefing on global business news.

Business News
AirlinesAutomobilesFoodPharmaceuticalsPolitics & GovernmentRetail & EcommerceSpace & AerospaceEarnings
Technology
A.I.ComputingConsumer TechSpace & AerospaceEarnings
Money & Markets
Economic IndicatorsMarketsPersonal FinanceEarnings
Lifestyle
Cars & BikesCollectingEntertainmentFood & Fine DiningHealth and FitnessReal EstateTravel
Quartz

Global business news for a smarter world

Topics

  • Business News
  • Money & Markets
  • Tech & Innovation
  • Generation A.I.
  • Lifestyle
  • Leadership

Products

  • Daily Brief
  • Weekly Digest
  • Member Benefits
  • Quartz Pro

Legal

  • Sitemap
  • About
  • Accessibility
  • Privacy
  • Terms of Service
  • Advertising

© 2026 Quartz Media, Inc. All rights reserved.

Business News

CMS and FDA are creating a fast-track Medicare coverage pathway for breakthrough devices

The RAPID pathway could cut the wait for Medicare coverage from over a year to about 2 months after FDA market authorization

2 min read·Updated April 24, 2026
Add QZ to Google

The Centers for Medicare & Medicaid Services and the Food and Drug Administration announced a new joint coverage pathway called the Regulatory Alignment for Predictable and Immediate Device, or RAPID, designed to speed Medicare access to certain FDA-designated Class II and Class III Breakthrough Devices.

Under the pathway, CMS will issue a proposed National Coverage Determination the same day an eligible device receives FDA market authorization, triggering a required 30-day public comment period. That timeline could allow Medicare coverage and payment to begin about two months after market authorization, compared to roughly a year or more under the current process, according to CMS.

The pathway works by bringing the two agencies and device manufacturers together earlier in the development process, so that clinical evidence gathered for FDA review can also support Medicare coverage decisions. To qualify, devices must be the subject of an Investigational Device Exemption study that enrolls Medicare beneficiaries and examines clinical outcomes agreed upon by both agencies. Eligible Class II devices must also participate in the FDA's Total Product Life Cycle Advisory Program, while Class III devices are eligible regardless of that program participation.

"FDA and CMS each play a critical role in getting new medical devices to patients, and they work most effectively when aligned sooner in that process," CMS Administrator Dr. Mehmet Oz said in a statement. "The RAPID coverage pathway brings our two agencies together earlier, cutting red tape for innovators, and helping beneficiaries access new, life-changing health technology faster."

FDA Commissioner Marty Makary said in a statement that the two agencies are "functioning as a single team to deliver life-saving Breakthrough Devices to American patients as soon as we know they work."

CMS said it will pause its Transitional Coverage for Emerging Technologies pathway for new candidates as it focuses on implementing RAPID. The agency said it will continue to offer other existing coverage pathways, including the standard process for opening, deciding, or reconsidering national coverage determinations.

A proposed procedural notice outlining the RAPID pathway will be published in the Federal Register, with a 60-day public comment period. The pathway is expected to take effect upon publication of a final notice. The device industry has long pushed for automatic reimbursement upon FDA clearance, a threshold STAT News notes the new pathway falls short of.

Related Content

Robinhood is launching a $200 million IPO for its second venture fund
JPMorgan Chase is pledging $750 billion to boost U.S. housing supply and homeownership