The coverage with evidence development (CED) process employed by the U.S. Medicare program may suffer from underutilization, but the authors of a new article in Value in Health see the attendant problems as administrative in nature. The issues include, but are not limited to, a lack of predictability as to when a CED study would be required for coverage of a medical device.
The U.S. House Committee on Ways and Means held a field hearing in the State of Utah, during which committee chairman Rep. Jason Smith (R-Mo.), highlighted the need to continue to incentivize life science research in the U.S. Smith remarked that Republican members of the committee have formed “tax teams” to find ways that the tax code can be tweaked to “better incentivize research and development here in the U.S.,” another sign that the well-being of life science commerce is seen as a macroeconomic imperative in Washington.
Guardant Health Inc.agreed to pay more than $900,000 to settle allegations that the company’s human resources office hired a relative and a friend of a physician who persuaded the company to make the hires in a quid pro quo for orders of Guardant’s tests. The U.S. Department of Justice said the penalties could have been much greater but for the company’s cooperation in the investigation, which disclosed that at least one of these hires was not qualified for the position.
The U.S. Court of Appeals for the Federal Circuit has upheld a district court decision that Natera Inc. is entitled to an injunction of a Neogenomics Inc. assay for detection of circulating tumor DNA (ctDNA). This outcome serves as a sobering reminder that injunction can be obtained at the preliminary injunction stage by demonstrating that an effort to prove infringement is likely to succeed even in the absence of a thorough evaluation of the contested claims in that patent.
A dongle is not the sort of thing one typically associates with a medical device, but a charging dongle used with the Baxter Healthcare Life2000 ventilator has triggered a recall of both the dongle and the ventilator.
A committee of the U.S. House of Representatives proposed an FDA discretionary spending bill of less than $26 billion in appropriated taxpayer dollars for fiscal year 2025.
The U.S. FDA’s final guidance for device-based treatments for opioid use disorder breaks little new ground relative to the 2023 draft, including a call for the use of a randomized, controlled clinical trial that retains blinding of not just enrollees, but also of the clinicians taking part in these studies.
The U.S. Medicare outpatient draft for 2025 is rich with applications for pass-through payment, but the draft also would boost payment for radiopharmaceuticals, a proposal that drew the applause of industry and physicians alike.
The U.S. Medicare physician fee schedule for 2025 appears set to reduce the number of services that can be provided via telehealth, but the proposed rate cut of 2.8% for physician services triggered a backlash from specialty medical societies, which seem destined to lobby Capitol Hill for a reversal of these cuts.
In the recently cast shadow of the U.S. Supreme Court’s Loper Bright decision that unraveled Chevron deference for federal agencies, the FTC’s broad rule banning noncompete employment clauses is on shaky ground. The first tremor hit July 3 when the U.S. District Court for the Northern District of Texas temporarily enjoined the FTC Noncompete Rule that is scheduled to go into effect Sept. 4 on the grounds that the agency overstepped its authority.