Edwards Lifesciences Corp. made a splash recently with the U.S. FDA approval of the Evoque tricuspid valve replacement device, but is also pressing Centers for Medicare and Medicaid Services to provide a coverage framework for this class of devices.
The draft Medicare physician fee schedule for calendar year 2025 provoked a strong backlash from physician societies due to a net cut in physician pay. Device makers have their own concerns, including the latest in a series of controversies over coverage of skin substitutes.
The U.S. CMS believes it has a quandary on its hands with regard to transitional pass-through payment for renal denervation devices, but the Medical Device Manufacturers Association urged the agency to provide separate payment mechanisms for these devices as seen in the inpatient final rule.
The U.S. FDA draft guidance for enforcement of in vitro diagnostics for emergent threats without a public health emergency has proposed some significant restrictions, which drew several negative responses.
The proposal to overhaul the use of terminal disclaimers in U.S. patent filings won over no fans among former directors of the U.S. Patent and Trademark Office, but device and drug makers, too, are concerned about the proposal.
The proposal to overhaul the use of terminal disclaimers in U.S. patent filings won over no fans among former directors of the U.S. Patent and Trademark Office, but device and drug makers, too, are concerned about the proposal.
The U.S. CMS has floated an alternative payment model dubbed the Transforming Episode Accountability Model for Medicare beneficiaries in fee-for-service care, but some in industry have misgivings about the proposal.
The U.S. appeals court for the District of Columbia has reversed a lower court’s ruling that the device industry cannot appeal a Library of Congress rule that allows third-party access to the software used to govern the operations of medical devices. While the latest outcome in this controversy is a win for device makers, the trajectory of this case is anything but certain as the next step may be an en banc hearing at the circuit court or an appeal to the U.S. Supreme Court.
The U.S. FDA’s draft guidance for control of thermal effects of medical devices may not have broken new conceptual ground, but two trade associations are of the view that the draft is nonetheless expansive in a manner that raises serious questions.
The U.S. FDA’s reissued draft guidance for pre-submission activity addresses the circumstances in which a manufacturer’s questions can be handled informally, but industry has a few misgivings about the draft. One of these is that a preformatted template proposed by the FDA would limit the number of topics that can be handled in an informal manner, which the Advanced Medical Technology Association said might drive more utilization of formal pre-submission programs, an outcome that would thwart the intent of these informal interactions.
