April 17, 2020
Current Centers for Disease Control and Prevention (CDC) figures show a total of 661,712 confirmed and presumptive positive cases of COVID-19 in the U.S. in 55 states and U.S. territories, with 33,049 deaths. New York state leads the nation with more than 216,000 cases, followed by New Jersey which has more than 75,000 cases and Massachusetts which has more than 32,000 cases.
The U.S. Food and Drug Administration (FDA) issued temporary guidance on the compounding of certain drugs for hospitalized patients during the COVID-19 pandemic. Hospitals have expressed they are having difficulties accessing FDA-approved drug products for use in COVID-19 patients. The guidance allows temporary flexibility for hospitals to acquire these drugs from outsourced FDA-registered compounding facilities. The guidance outlines the requirements and specific drug products.
The FDA urges those who have fully recovered from COVID-19 to donate their plasma for an FDA investigation on how it has the potential to lessen the severity or shorten the length of illness caused by COVID-19. The FDA has launched a new webpage to guide recovered COVID-19 patients to local blood or plasma collection centers to discuss their eligibility and potentially schedule an appointment to donate. The webpage also provides information for those interested in participating in the expanded access protocol, conducting clinical trials or submitting emergency investigational new drug applications.
The National Institutes of Health (NIH) and the Foundation for the NIH (FNIH), along with more than a dozen leading biopharmaceutical companies, the Health and Human Services Office of the Assistant Secretary for Preparedness and Response, the Centers for Disease Control and Prevention, the FDA and the European Medicines Agency, have partnered to develop an international strategy for a coordinated research response to the COVID-19 pandemic. The planned Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership will develop a collaborative framework for prioritizing vaccine and drug candidates, streamlining clinical trials, coordinating regulatory processes and/or leveraging assets among all partners to rapidly respond to the COVID-19 and future pandemics. Read more here.
The FEMA Healthcare Resilience Task Force created a COVID-19 Hospital Resource Package. The document contains guidance and resources for hospital administrators, hospital emergency planners and infection control practitioners in the following areas: hospital surge, crisis standards of care, staffing surge and resilience, workforce protection, regulatory relief, equipment supply surge and telemedicine.
The Centers for Medicare & Medicaid Services (CMS) is housing all of its COVID-19 conference calls, open door forums, and webinar transcripts and audio recording, along with its podcasts, on a central webpage for easy access. The page will be updated as materials become available.
CMS recently ruled to increase Medicare reimbursement for COVID-19 testing performed using high-throughput technologies to $100. Reimbursements using other diagnostic technologies continue to be reimbursed at $51.
Responding to a spike in cyber threats that exploit telework technologies during the COVID-19 pandemic, the AMA and the AHA have teamed to provide physicians and hospitals with guidance on protecting a remote work environment from cyber criminals. The resource includes checklists, sources, tips and advice on strengthening protections to keep pace with deceptive cyberattacks that could disrupt patient care or threaten medical records and other data.