1/12+ CMS COVID Calls

CMS will hold an hour-long COVID “Office Hours” call at 2pm PST January 12, 2021. Call in to 833-614-0820 using access passcode 4688247, or use the audio webcast link at https://edge.media-server.com/mmc/p/p5jw6syi. They haven’t announced a second date, but they have indicated their intention to offer this call twice a month.

They will also offer a 1pm PST January 13, 2021 call on COVID-19 Vaccine Safety: A Fireside Chat with CMS, CDC, and front line staff and providers. Register in advance at https://cms.zoomgov.com/webinar/register/WN_VQnfc77zTaOho3-yYrtGUA. After registering you will receive a confirmation email containing information about joining the webinar. This call will be repeated at 1pm PST on January 20 and January 27, 2021.

Find more information and updates at https://www.cms.gov/outreach-education/partner-resources/coronavirus-covid-19-partner-toolkit.

FDA Warnings re COVID-19 False Test Results

The FDA has issued two different warnings about false negative COVID-19 test results:

They have warned that the Curative SARS-Cov-2 test may provide false results that could threaten the safety of patients and staff, providing details and recommendations at https://www.fda.gov/medical-devices/safety-communications/risk-false-results-curative-sars-cov-2-test-covid-19-fda-safety-communication.

They have also warned that all SARS-CoV-2 molecular tests may provide false negatives on mutations of the virus, providing details and recommendations at https://www.fda.gov/news-events/press-announcements/fda-issues-alert-regarding-sars-cov-2-viral-mutation-health-care-providers-and-clinical-laboratory.

1/7 ASN+ Webinar on Vaccine Safety in ESRD

ASN, AAKP, AKF, ANNA, CDC, NANT, NKF, RPA, and the Renal Healthcare Association (formerly the NRAA) are collaborating to sponsor a January 7, 2021 webinar on Safety and Efficacy of COVID-19 Vaccines in the Dialysis Population. Webinar topics will include available information about the safety and efficacy of the current COVID-19 vaccines for health care workers and patients with CKD, the risk of poor outcomes in those contracting COVID-19, the position of the sponsors on urging dialysis patients to get vaccinated, possible concerns about receiving the vaccine, approaches to discussing and defusing those concerns, and a strategy to share the provided information widely. Find more information and register at https://goto.webcasts.com/starthere.jsp?ei=1416384&tp_key=2914871054.

Possible New QIP Measures

CMS is in the process of deciding which new measures to add to its Quality programs. For the ESRD QIP, measures under consideration include in-center patient Coronavirus vaccination coverage, health care personnel Coronavirus vaccination coverage, and Standardized Hospitalization Ratio. For details see https://www.cms.gov/files/document/measures-under-consideration-list-2020-report.pdf – suggested new ESRD measures are summarized on p.82. Measures under consideration are being sent to the National Quality Forum’s Measure Applications Partnership (https://www.qualityforum.org/map/). After the “MAP” has evaluated them, measures still under consideration will be published in the Federal Register for public comment sometime after February 1, 2021.

CDC: Monitor Vaccine Recipients

CDC says that during administration of the Pfizer COVID-19 vaccine, “appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event that an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 vaccine. Vaccine providers should observe patients with a history of anaphylaxis (due to any cause) for 30 minutes after vaccination. All other persons should be observed for 15 minutes after vaccination to monitor for the occurrence of immediate adverse reactions.” See https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/clinical-considerations.html for a full description of all CDC recommendations around the Pfizer COVID-19 vaccine, including triage and adverse reaction reporting instructions near the bottom of the web page.

CDC Vaccine Safety Surveillance

Vaccine Adverse Event Reporting System (VAERS): https://vaers.hhs.gov/

VAERS is a website operated by both the CDC and the FDA to monitor vaccination safety. Here you can report adverse events for all patients regardless of the plausibility of the vaccine causing the event or the clinical seriousness of the event. This helps the nation monitor the safety of the vaccine for all patients; we can rapidly detect potential side effects and identify rare adverse events. For COVID-19, the FDA will issue VAERS reporting requirements under the EUA. To report an adverse event to VAERS, you can submit a report online at  https://vaers.hhs.gov/. If you need help, call 800-822-7967, email info@VAERS.org, or watch the instructional video https://youtu.be/sbCWhcQADFE.

V-safe: Active safety monitoring for COVID-19 vaccines https://vsafe.cdc.gov/

V-safe is a new CDC smartphone-based monitoring program for COVID-19 vaccine safety. It uses text messaging and web surveys to check-in with vaccine recipients after vaccination. Participants can report side effects and health impact events after COVID-19 vaccination and it includes active telephone follow-up by CDC for reports of significant health impact. V-safe conducts electronic health check-ins with vaccine recipients daily for the first week post-vaccination and weekly until 6 weeks post-vaccination, additional health checks at 3, 6, and 12 months post-vaccination, and the timeline resets at 2nd dose. CDC asks that healthcare providers get as many people to use v-safe as possible by giving them the one-page info sheet at the time of vaccination (https://www.michigan.gov/documents/mdhhs/v-safe-information-sheet_709444_7.pdf) and educating patients on the importance of enrolling in v-safe.

12/17 COVID Vaccine Safety Webinar

Washington State DOH will host a December 17, 2020 COVID-19 Vaccine Safety Webinar for health care providers. It will cover COVID-19 epidemiology, COVID vaccines, vaccine testing and approval, vaccine adverse events, and other safety resources. Continuing education credit is available for nurses, medical assistants, pharmacists and physicians. Find more information and register at https://register.gotowebinar.com/register/8511091222749618187.