A bipartisan group of members of the U.S. House of Representatives said in a letter to the that body’s leadership that there is a pressing need to ramp up production of injection needles and syringes in preparation for a vaccine for the COVID-19 pandemic. The letter, addressed to House Speaker Nancy Pelosi (D-Calif.) and Republican leader Kevin McCarthy (R-Calif.) noted that universal administration of a vaccine would require more than 300 million needles and syringes and that current production capacity might struggle to keep up, particularly in the event that a vaccine requires more than one dose. They urged that any further legislation that gives funding for the pandemic provide resources for needles and syringes. The letter was signed by 25 House members.
Sen. Shelley Moore Capito (R-W.V.) said in a June 3 statement that she and two other senators have proposed legislation that would boost the penalties for false advertising of products for the COVID-19 pandemic by a factor of 10. The Combating Egregious Advertising through Sentencing Enhancement (CEASE) Act of 2020 would increase fines levied by the Federal Trade Commission from $5,000 per first incident to as much as $50,000, while jail time could increase from six months to a year. Repeat offenders, who would be subject to felony charges, could be subject to fines of as much as $250,000 and five years in prison. Capito, whose co-sponsors are Sens. Kyrsten Sinema (D-Ariz.) and Cory Gardner (R-Colo.), said the bill would ensure that malicious actors “who conduct these scams face increased monetary and jail time penalties.”
The U.S. National Institute for Standards and Technology (NIST) said in a Federal Register notice that it is forming the Rapid Microbial Testing Methods consortium for development of standards related to rapid microbial tests to aid in development of regenerative medicine products. The task of the consortium will be to foster the development of reference materials and collect data that will be used to draft a set of best practices and standard methods. NIST said there is no cost for taking part in the effort, which will commence Sept. 15. Interested parties can contact NIST’s Nancy Lin at firstname.lastname@example.org.
The U.S. Federal Communications Commission (FCC) has approved another 53 funding applications for telehealth as part of the agency’s programmatic response to the COVID-19 pandemic per the CARES Act. The additional 53 programs will make use of nearly $16.5 million, bringing the total awarded to date to roughly $85 million. The FCC has access to $200 million for this program.
The U.K. National Institute for Health and Care Excellence said health care professionals (HCPs) should engage in shared decision-making practices with patients in regard to hip, knee and shoulder joint replacement procedures. The committee that drafted the recommendations did not make recommendations about decision aids to be used toward such decision-making processes but said that families and other HCPs also should be included in any such consultations.
Palmetto GBA, of Columbia, S.C., said it has extended the comment period for its draft local coverage determination (dLCD) for a fluid Jet system for treatment of benign prostatic hyperplasia to July 7, roughly a five-week extension past the initial closing date of June 3. The dLCD addresses the Aquabeam system from Procept Biorobotics that has been the subject of a new technology add-on payment that the Centers for Medicare and Medicaid Services may terminate at the end of the current fiscal year. Palmetto said it had opened the coverage analysis to align coverage with other Medicare administrative contractor jurisdictions.