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FDA, CMS to launch speedy coverage pathway for breakthrough medical devices

Certain breakthrough-designated medical devices that receive market authorization will become eligible for Medicare coverage at the same time under a new coverage pathway announced Thursday by the FDA ...
JD Supra

New Coverage Pathway for Medical Devices

Last week, the Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) unveiled a proposed program aimed at dramatically accelerating Medicare coverage for ...
Healthcare Finance News

CMS and FDA announce RAPID Medicare coverage for breakthrough medical devices

The Centers for Medicare & Medicaid Services has introduced a new coverage pathway for Medicare beneficiaries to get expedited coverage for breakthrough medical devices. On Thursday, CMS and the Food ...
STAT

Fixing the reimbursement and coverage divide between ‘breakthrough’ drugs and medical devices

The Food and Drug Administration designates as “breakthrough” technologies certain drugs and devices. This designation helps expedite the development and review of therapies intended to treat serious ...
qz

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

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, ...
RAPS

FDA, CMS propose new parallel review pathway for breakthrough devices

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have proposed a parallel review program to expedite certain Class II and Class III breakthrough ...
Fierce Healthcare

CMS, FDA announce new program to speed up Medicare coverage of breakthrough medical devices

The RAPID pathway is designed to accelerate access to certain FDA-designated Class II and Class III devices for people with Medicare coverage, CMS and FDA officials said. (Inna Knot/GettyImages) The ...
Healthcare Dive

CMS, FDA unveil speedier Medicare coverage pathway for breakthrough devices

The CMS and the Food and Drug Administration have unveiled a new pathway to speed up Medicare coverage for certain breakthrough medical devices. The pathway, called the Regulatory Alignment for ...
STAT

Medicare’s new RAPID pathway is a breakthrough for adults. Children are still waiting

Eskandanian is a senior research scientist at MedStar Health Research Institute, program director of the BARDA-funded SPARK for Innovations in Pediatrics, and founding principal investigator of the ...
JD Supra

CMS and FDA Announce RAPID Coverage Pathway to Accelerate Medicare Coverage for Breakthrough Medical Devices

The RAPID coverage pathway is designed to address the historically significant lag (sometimes referred to as the “valley of death”) between the point at which a medical device receives FDA market ...