The U.S. Department of Health and Human Services (HHS) has extended the designation of scarce or threatened materials subject to hoarding prevention measures for another 120 days past July 23. HHS posted the announcement in the July 30 issue of the Federal Register, adding laboratory reagents to the list of materials that are subject to the policy. Also added are remdesivir and dexamethasone, both of which are pharmaceutical agents used in treatment of COVID-19, along with a number of alcohol-based hand sanitizers and rubs. Among the articles that reappear on the list are several types of masks (N95 and surgical masks along with face shields) and ventilators.
The U.S. Solicitor General (SG) has filed an amicus brief regarding a petition for writ of certiorari with the U.S. Supreme Court to address the question of the constitutionality of appointments to the Patent Trial and Appeal Board (PTAB), a controversy engendered by the October 2019 decision by the Court of Appeals for the Federal Circuit in Arthrex v. Smith & Nephew. Acting SG Jeffrey Wall, who has taken the position temporarily after the departure of Noel Francisco, named Image Processing Technologies LLC, as the respondent. The SG’s brief states that the Federal Circuit had allowed Arthrex Inc., of Naples, Fla., to challenge whether judges on the PTAB were appropriately appointed under the Appointments Clause, even though counsel for Arthrex had failed to make the argument while the underlying patent case was under inter partes review. This, the brief said, was based on reasoning “that would apply to nearly all separation-of-powers challenges,” creating what Wall described as “a constitutional infirmity.” The outcome in the Federal Circuit decision in Arthrex was followed by similar outcomes in another 39 cases, and the brief states that should the Supreme Court ultimately overturns the Federal Circuit’s decision via an associated petition for cert (docket no. 19-1434), the Federal Circuit’s decisions in the other cases cited would be undermined. Wall said that this latest petition by Arthrex (docket no. 19-1458) should be suspended pending the Supreme Court’s disposition of the previous petition for cert and any associated proceedings at the Supreme Court.
The U.K.’s Medicines and Healthcare Products Agency (MHRA) Wednesday announced the creation of two synthetic datasets to help in the development of medical technologies to fight COVID-19 and cardiovascular disease. The datasets were generated to accurately mirror symptoms, diagnoses and treatments in patients, based on anonymized primary care data that was transformed into artificial data containing no original data from “real” patients, the MHRA said. The synthetic datasets can be used in the development and testing of machine learning and artificial intelligence algorithms in medical devices used for diagnosing diseases and monitoring and improving health conditions.
The U.S. Department of Health and Human Services (HHS) said a new report highlights “dramatic utilization trends” in the use of telehealth primary care services under Medicare fee-for-service programs as seen in data spanning the first six months of calendar year 2020. HHS said in-person primary care visits “fell precipitously” by mid-March, and that 43.5% of these encounters were handled via telehealth in April. In contrast, only 0.1% of such visits occurred in February, although the uptick in rural use was proportionally smaller. Nonetheless, telehealth visits in the state of Nebraska accounted for 22% of all visits in April, while nearly two thirds of such visits were telehealth visits in Boston. An investor note from Cowen Washington Research Group said the trend toward more frequent use of telehealth visits has persisted in May, June and July, even after primary care visits resumed, which the authors said is an indication of a permanent, long-term change in how both Medicare beneficiaries and others view telehealth.