breakthrough device Archives - Medical Design Sourcing

Medtech gets behind breakthrough device law for seniors

Congressional Democrats and Republicans today introduced a bill to provide Medicare coverage for devices granted FDA breakthrough designation.

Sponsored by U.S. Reps. Suzan DelBene (D-Wash.), Jackie Walorski (R-Ind.), Tony Cárdenas (D-Calif.), Gus Bilirakis (R-Fla.), Terri Sewell (D-Ala.) and Fred Upton (R-Mich.), the Ensuring Patient Access to Critical Breakthrough Products Act would codify an effort that the Centers for Medicare and Medicaid Services (CMS) has delayed implementing with a final rule.

Get the full story on our sister site, Medical Design & Outsourcing.

CMS delays Medicare payments for breakthrough devices until December

Medicare coverage for FDA-designated breakthrough medical devices will have to wait several more months, despite broad support.

The Centers for Medicare and Medicaid Services (CMS) issued a final rule on Medicare Coverage of Innovative Technology (MCIT) in January, granting coverage for breakthrough devices the same day as their FDA approvals, for up to four years.

Immediately upon taking office, the Biden administration asked federal agencies to consider delaying the effective date of rules published in the Federal Register to review questions of fact, law and policy the rules may raise. CMS officials decided that coverage of breakthrough devices warranted further review.

Get the full story on our sister site, Medical Design & Outsourcing.

Medicare to cover breakthrough devices

FDA-designated breakthrough devices will have Medicare coverage the same day they are approved, under a final rule issued this week by the Centers for Medicare and Medicaid Services (CMS).

The Medicare Coverage of Innovative Technology (MCIT) rule will provide national Medicare coverage as early as the same day as FDA market authorization for breakthrough devices and certain diagnostic tests. The coverage would last for four years, during which CMS would specify what additional data, if any, would be needed to maintain coverage after the four-year coverage period expires.

Get the full story on our sister site, Medical Design & Outsourcing.

CMS agrees to cover ‘breakthrough’ medical devices

Medicare patients will have coverage for medical devices the FDA designates as breakthrough technology under a proposed rule released this morning.

Once the Medicare Coverage of Innovative Technology (MCIT) final rule goes into effect, national Medicare coverage will begin on the date of a breakthrough device’s FDA market authorization would begin and continue for 4 years.

The proposed rule, scheduled to be published September 1 in the Federal Register, has been under discussion for years and would remedy a nationwide patchwork of Medicare coverage for such devices. Currently, a breakthrough device may be covered in one state or area of a state and not another, depending upon a local coverage determination made by a Medicare administrative contractor.

The MCIT pathway would be voluntary and device manufacturers would notify the Centers for Medicare and Medicaid Services if they want to use this coverage option.

“This coverage pathway d…

Laminate Medical lands FDA breakthrough nod for dialysis device

Laminate Medical Technologies today announced it has won FDA breakthrough device designation for its VasQ external support for patients in need of an arteriovenous fistula (AVF) for hemodialysis.

Tel Aviv, Israel–based Laminate’s VasQ device is a nitinol external support placed around the artery and vein at the creation site. It is designed to optimize the transition of arterial flow to the vein while it reinforces the vessel wall against an increase in mechanical stress.

The company completed enrollment of a U.S. investigational device exemption pivotal trial in February. A total of 144 current and pre-dialysis patients referred for fistula creation were included in the study for either a brachiocephalic or radiocephalic fistulas with VasQ. Follow-up for the study’s primary endpoints are expected by August 2020 and will be evaluated by the FDA through the de novo pathway, according to Laminate Medical. The patients will be followed for two years.

…