The U.S. Centers for Disease Control and Prevention (CDC) said it has developed a real-time reverse transcription-polymerase chain reaction test for the 2019-nCoV, the formal name for the Wuhan type coronavirus. The CDC said in a Jan. 22 update that testing at present must take place at its headquarters in Atlanta. However, it intends to share that technology with domestic and international partners via the CDC International Reagent Resource depository. The Wuhan virus has triggered widespread screening efforts at major airports in the U.S. and other destinations for flights leaving mainland China.
The U.S. FDA issued a safety communication regarding a purported cybersecurity vulnerability in certain health care clinical information central stations and telemetry servers made by GE Healthcare, of Waukesha, Wis. The notice is directed to the Apex Pro telemetry server with software version 4.2 and earlier, the Carescape central station (all editions of version 1.x) and the CIC Pro clinical information center central station edition 1 (updates under versions 4.x and 5.x). GE said it will issue a patch to resolve the vulnerabilities, and that among the available measures to be taken in the interim are segregation of patient monitors from non-GE hospital data systems and the use of firewalls and virtual private networks.
The Innovation Center at the U.S. Centers for Medicare and Medicaid Services said in a January bulletin that the Comprehensive Care for Joint Replacement (CJR) bundled payment program had reduced per-episode payments by 3.7% in the first two years of the program. That difference equates to a savings of $997 per episode, although the net effect on Medicare spending for this and another bundled payment program was characterized as negligible due to the associated reconciliation payments to program participants. The other program cited in this context was the Bundled Payments for Care Improvement program, and CMS said that rate-setting for these and other bundled payment programs is difficult due to “a substantial amount of variability” in the underlying cost data. Beneficiary attribution and overlap between incentive programs are also confounders, the agency said, adding that the bulk of the savings came from the post-acute care phase.
Eric Assaraf and Joshua Jennings, analysts with Cowen Washington Research Group, said device makers are at less risk from bundled care programs than clinicians who provide post-acute care, principally because hospitals have several options regarding choice of discharge destination. While the initial five-year pilot for the CJR does not conclude until the end of the current calendar year, Jennings and Assaraf said they expect the CMS to extend the program given its appearance in the regulatory agenda for the Office of Management and Budget. The program’s reach may be expanded, however, in terms of geography and/or types of joint replacement procedures. They added that there is less drag on the continuation of an existing bundled payment program than on initiation of a novel one, citing the radiation oncology advanced payment model (RO-APM) as an example of the latter, which may not go into force until 2021. The CJR entry at the OMB docket, which appears under regulatory ID number 0938-AU01, was slated for rulemaking in November 2019.
The European Commission said it received three applications for new notified body (NB) status for the Medical Device Regulations, although one of the applicant entities withdrew from consideration from certification. Another applicant has filed for the in vitro diagnostics regulations, and the notified bodies database, the NANDO listing, features nine such entities that are approved by the Commission. More than 80% (40 of 49) of the NBs currently authorized under the regulations for medical devices have applied for authorization, but only half the 20 NBs authorized under the in vitro diagnostic regulations have applied. The slow pace of authorization has industry concerned about the implementation date of the new Medical Device Regulations, which are formally in force before the end of May 2020.