STAT

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

The pediatric and orphan pipeline is already the smallest, slowest, and least capitalized segment of the device industry,” ...
Regulatory Affairs Professionals Society

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 ...
JD Supra

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

Faster Medicare Coverage. The Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration ...
Medical Design & Outsourcing

FDA, CMS unveil accelerated Medicare coverage pathway for breakthrough devices

RAPID could enable Medicare coverage and payment as soon as two months after FDA approval, compared to a year or more with ...
Hosted on MSN

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 ...
Fierce Healthcare

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

The Trump administration unveiled a new program to speed up Medicare coverage for breakthrough devices, touting that the new pathway cuts red tape for medical device companies to gain reimbursement.
Medical Device Network on MSN

FDA and CMS outline new Medicare coverage pathway for medical device access

The agencies’ initiative is intended to speed up the processes involved in medical devices’ securing Medicare coverage once ...
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 ...
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 ...