The U.S. FDA’s Center for Devices and Radiological Health is seeking nominations for the patient engagement advisory committee for both current and impending vacancies. Nominations the agency receives by March 30 will be considered for existing vacancies, while those received after that date will be considered for positions that will vacate later. Members are invited to serve for terms of four years. The agency is taking comment and nominations at docket number FDA-2020-N-0008.
The U.S. NIH has named John Ngai to direct the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative. Ngai is a professor of neuroscience at the University of California, Berkeley and will oversee both day-to-day operations and long-term strategy for the program. NIH Director Francis Collins said the agency welcomes Ngai’s leadership “in steering this groundbreaking 21st Century project.”
Samuel Caughron, chairman of the economic affairs committee for the Association for Molecular Pathology (AMP), said his organization is pleased that the U.S. Centers for Medicare and Medicaid Services (CMS) took the association’s comments into account when finalizing the Medicare policy for next-generation sequencing (NGS). Caughron said AMP is still reviewing the revised Medicare final national coverage determination for NGS but lauded the decision to allow Medicare administrative contractors to cover tests for all inherited cancers. However, he did note that AMP is concerned that the failure to devise a technology-agnostic policy will force the CMS to periodically revisit its coverage policy for gene testing.
The Office of Inspector General (OIG) at the U.S. Department of Health and Human Services said non-mail order claims for glucose test strips accounted for 85% of all test strips ordered by Medicare beneficiaries from April 1-June 30, 2019. The report noted that competitive bidding for these strips had ceased for all of calendar year 2019 that the bidding program requires that a supplier make available at least half of the test strip types that might be used by beneficiaries. The OIG analysis was based on a random sample of 600 claims for non-mail order and another 600 claims for mail-order strips. The non-mail providers were able to offer, on average, 25 types of test strips, whereas the mail-order sources offered 21 types.
Scott Whitaker, president and CEO of the Advanced Medical Technology Association, said the U.S.-Mexico-Canada Trade Agreement (USMCA) “is a strong step forward for the med-tech industry and the patients we serve.” Whitaker was reacting to the news that President Donald Trump had signed the agreement after the U.S. Senate ratified the deal Jan. 29. While Canada has yet to ratify the agreement, which replaces the North American Free Trade Agreement, Whitaker said the USMCA will increase access to medical technology and is “great news for American jobs in the med-tech sector.”
The Trump administration announced Jan. 29 that it has formed a task force to respond to the Wuhan coronavirus (2019-nCoV), which has led to the quarantine of nearly 200 U.S. citizens as of Jan 30. In addition to Health and Human Services Secretary Alex Azar, the task force consists in part of Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the NIH, and Robert Redfield, director of the U.S. Centers for Disease Control and Prevention. The administration’s Jan. 29 statement does not list a member of the FDA.
The U.S. Centers for Medicare and Medicaid Services has posted a technology assessment for the use of cardiac resynchronization therapy with defibrillation (CRT-D) compared to resynchronization without defibrillation (CRT-P), stating that there is no new definitive evidence since 2015 that CRT-D improves outcomes over CRT-P in select patient populations. The report, filed by the Agency for Healthcare Research and Quality, focuses on patients with left ventricular ejection fractions of 35% or less and QRS durations of at least 120 milliseconds who had been managed via medical therapy. The report affirms the finding of the 2015 edition that CRT-D is associated with improved outcomes in patients with left bundle branch morphology, nonischemic cardiomyopathy, and in women. There were no observed differences between CRT-D units and implantable cardioverter defibrillators for inappropriate shock, pocket hematoma, and cardiac tamponade, although CRT-D devices were associated with higher rates of left ventricular lead dislodgment at 24 hours. Quadripolar leads were said to be associated with lower rates of dislodgment than bipolar leads, likely an artifact of more stable positioning and greater sensing/pacing configurations. However, the authors cited a relative paucity of data from patients aged at least 75 years, those with more numerous comorbidities, patients deemed frail, and those identified with functional and/or cognitive impairment.
The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) has put in place a process by which medical device manufacturers can continue to offer their products while transferring them to new notified bodies (NBs). At least one NB has withdrawn its certification to serve in the U.K. UL International announced in July 2019 that it was transferring its CE mark customers to other NBs and would retain authorization for in vitro diagnostics to only one test type. To qualify for the grace period, manufacturers will have to document their efforts to transition to a new NB for its products. MHRA did not specify a fixed grace period.