CDC COCA Call: Johnson & Johnson/Janssen COVID-19 Vaccine and Cerebral Venous Sinus Thrombosis with Thrombocytopenia; CDC and FDA Recommend a Pause in Use of Johnson & Johnson COVID-19 Vaccine; REMINDER: 2021 Call for MIPS Promoting Interoperability Measures and Improvement Activities Now Open

Centers for Medicare & Medicaid Services
Quality Payment Program

CDC COCA Call: Johnson & Johnson/Janssen COVID-19 Vaccine and Cerebral Venous Sinus Thrombosis with Thrombocytopenia

This CDC Clinician Outreach and Communication Activity (COCA) Call will present the latest evidence on cerebral venous sinus thrombosis (CVST) with thrombocytopenia associated with the administration of the Johnson & Johnson/Janssen COVID-19 vaccine. Speakers will discuss what is known about CVST, the importance of early detection, and updated vaccine recommendations.

If you are unable to attend the live COCA Call, the recording will be available for viewing on the COCA Call webpage a few hours after the live event ends.

Continuing Education (CE) will not be provided for this call.

Advanced registration is not required.

  • Date: Thursday, April 15, 2021
  • Time: 2:00 - 3:00 p.m. ET
  • Telephone: 669-254-5252
  • Webinar ID: 161 433 6614
  • Passcode: 160026
  • Click here to join

COCA Call Objectives

At the conclusion of the session, the participant will be able to accomplish the following—

  1. Cite background information on the topic covered during the presentation.
  2. Discuss CDC’s role in the topic covered during the presentation.
  3. Describe the topic’s implications for clinicians.
  4. Discuss concerns and/or issues related to preparedness for and/or response to urgent public health threats.
  5. Promote health improvement, wellness, and disease prevention in cooperation with patients, communities, at-risk populations, and other members of an interprofessional team of healthcare providers.

Presenters

Sara Oliver, MD

  • LCDR, U.S. Public Health Service
  • Co-lead, Advisory Committee for Immunization Practices COVID-19 Vaccines Work Group
  • COVID-19 Response
  • Centers for Disease Control and Prevention

Tom Shimabukuro, MD, MPH, MBA

  • CAPT, U.S. Public Health Service
  • Vaccine Safety Team Lead
  • COVID-19 Response
  • Centers for Disease Control and Prevention

The Emergency Risk Communication Branch in the Division of Emergency Operations, Center for Preparedness and Response is responsible for the management of all COCA products.

For information about this update or other clinical issues, or to send your feedback, please contact us at coca@cdc.gov


CDC and FDA Recommend a Pause in Use of Johnson & Johnson COVID-19 Vaccine

Sharing an update from the Centers for Disease Control and Prevention (CDC).

This week, CDC and FDA recommended a pause in the use of the Johnson & Johnson (Janssen) COVID-19 vaccine pending an investigation into six reported U.S. cases of a rare and severe type of blood clot in individuals who received the vaccine. COVID-19 vaccine safety is a top priority for the federal government, and CDC takes all reports of health problems following COVID-19 vaccination very seriously.

If any residents or staff in your facility develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks of receiving the J&J vaccine, please seek medical care, and report the event to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html.

CDC has notified all federal pharmacy partners about the recommendation to pause the use of the J&J vaccine and is exploring options to minimize any potential interruption in ongoing access to vaccine for long-term care facility (LTCF) residents and staff. Importantly, CDC is not seeing these events with the Pfizer-BioNTech or Moderna COVID-19 vaccines.

We realize there may be concern among LTCF staff and residents who have received the J&J vaccine, but it’s important to note these adverse events appear to be extremely rare - with six reported cases out of more than 6.8 million doses of J&J vaccine administered in the U.S.. All of the cases occurred among women between the ages of 18 and 48, with symptom onset 6 to 13 days after vaccination.

CDC convened an emergency meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday, April 14 to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases.

Additional resources are below, and further guidance will be made available from the ACIP meeting.

 Thank you in advance for your cooperation.


REMINDER: 2021 Call for MIPS Promoting Interoperability Measures and Improvement Activities Now Open

Reminder: the Centers for Medicare & Medicaid Services (CMS) encourages you to submit Promoting Interoperability measures and Improvement Activities for consideration for future years of the Merit-based Incentive Payment System (MIPS). The MIPS Annual Call for Measures and Activities process allows clinicians, professional associations and medical societies that represent clinicians, researchers, consumer groups, and others to identify and submit measures and activities. Currently, we are accepting submissions for:  

  • Measures for the Promoting Interoperability performance category
  • Activities for the Improvement Activities performance category

What We’re Looking For

For Promoting Interoperability: CMS is looking for specific measures that build on the advanced use of certified EHR technology (CEHRT) using 2015 Edition Certification Standards and Criteria; promote interoperability and health information exchange; improve program efficiency, effectiveness, and flexibility; provide patients access to their health information; reduce clinician burden; and align with MIPS Improvement Activities and Quality performance categories.

For Improvement Activities: CMS is looking for activities that can be considered higher than the standard of care. This means that the sets of practices or activities being proposed for consideration exceed defined, commonly accepted guidelines for level of quality or attainment in clinical care or quality improvement guidelines. CMS will not accept duplicative concepts to existing or retired activities.

How to Submit Measures and Activities

If you’re interested in proposing new measures and activities for MIPS, review the 2021 Call for Measures and Activities Overview Fact Sheet in this toolkit (zip) and fill out and submit the forms from the toolkit for the following performance categories during the specified submission periods:

  • Promoting Interoperability Performance Category (Submission Period: February 1 – July 1, 2021 for 2023 measures)
  • Improvement Activities Performance Category (Submission Period: February 1 – July 1, 2021 for 2023 activities)

For More Information

  • Download the 2021 Call for Measures and Activities Toolkit (zip) in the Quality Payment Program (QPP) Resource Library.
  • Contact the Quality Payment Program at 1-866-288-8292 or by e-mail at: QPP@cms.hhs.gov. To receive assistance more quickly, consider calling during non-peak hours—before 10 AM and after 2 PM ET. We also encourage you to contact us earlier in the year, as response times often increase with heavier demand as the March 31 data submission deadline approaches.
    • Customers who are hearing impaired can dial 711 to be connected to a TRS Communications Assistant.