The U.S. National Institutes of Health said it will use $1.5 billion from federal stimulus funding to launch the Rapid Acceleration of Diagnostics, or RADx, initiative, intended to speed testing to market to deal with the COVID-19 crisis. This program will focus largely on early-stage technologies, but will also include an effort to push along advanced-stage technologies in a collaboration with the FDA, the CDC, and the Biomedical Advanced Research and Development Authority. The program includes an invitation to test developers to submit applications for a rapid, three-phase selection process for at-home and point-of-care tests, and early-stage finalists will be matched with technical, business and manufacturing expertise to bolster their odds of winning a grant. Late-stage technologies may be immediately advanced to the appropriate stage of commercialization, and NIH said the objective is “to make millions of accurate and easy-to-use tests per week available to all Americans by the end of summer, 2020, and even more in time for flu season.”
The U.S. Centers for Medicare and Medicaid Services said it is taking a number of measures to address the COVID-19 pandemic, which includes an expansion of the parties authorized to order a test for the SARS-CoV-2 virus. Ordinarily, a licensed health care practitioner must order a diagnostic test, but pharmacists will be able to order a test so long as the pharmacist is working with a health care professional. Pharmacists can also perform the test so long as the pharmacy is enrolled in Medicare as a laboratory. Both the Medicare and Medicaid programs will cover serology tests that rely on home sample collection, and Medicare telehealth services will be billable when performed by physical and occupational therapists as well as speech language pathologists. Payments for many telehealth services will more increasingly be aligned for the rates paid for those services in office and outpatient settings, and the agency said it will employ sub-regulatory notice to expand coverage and increase rates for telehealth.
The U.S. Federal Communications Commission announced that it has provided a conditional waiver that allows Terrestar Corp., of Vienna, Va., to offer wireless telemetry services in the 1.4 gigahertz band, a measure intended to ensure the reliability of medical telemetry monitoring in hospitals and in the provision of telehealth services. The FCC said Terrestar had failed to meet licensing requirements for this action in 2017, but that the agency reversed course due in part to a petition filed by the company and several other organizations, including the American Hospital Association.
U.S. Reps. Kim Schrier (D-Wash.) and Phil Roe (R-Tenn.) unveiled the Health Care at Home Act of 2020 (H.R. 6644), which they said “will ensure telehealth coverage for normally covered benefits, including mental health and substance use treatment,” for the duration of the COVID-19 emergency. The legislation is intended to ensure that any medically necessary benefit in plans under the Employee Retirement Income Security Act is covered via telehealth for the duration of the public health emergency. The bill would also establish payment parity between telehealth and face-to-face visits, including audio-only telehealth visits, and would prohibit restrictions on the conditions that can be managed remotely. The bill would further ensure that all cost-sharing requirements would be waived.
U.S. Rep. Stephen Lynch (D-Mass.) said H.R. 6607 would require that the Department of Health and Human Services and the National Biodefense Science Board to establish a National Emergency Biodefense Network that would employ blockchain technology to monitor the availability of supplies in the states and in the strategic national stockpile (SNS). The bill would also provide funding to set up state repositories and state-based blockchain nodes for tracking purposes. Lynch said, “throughout the COVID-19 crisis we have watched health care providers and centers pushed to their breaking points as they risk their lives to provide vital care to their communities,” adding that the bill would “ensure the readiness of the SNS to respond to future crises.” He said the use of a private blockchain system would allow verification of the status of the U.S. biodefense capacity in real-time.