Category: COVID

CMS Memo QSO-22-04-ALL: Vaccination Regulation: Enforcement of Rule Imposing Vaccine Requirement for Health Care Staff in Medicare-and Medicaid-certified Providers and Suppliers is Suspended so Long as Court Ordered Injunctions Remain in Effect

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Survey and Enforcement of the Vaccine Requirement for Health Care Staff in Medicare-and Medicaid-certified Providers and Suppliers Suspended While Court Ordered Injunctions are in Effect: The Centers for Medicare & Medicaid Services (CMS) will not enforce the new rule regarding vaccination of health care workers or requirements for policies and procedures in certified Medicare/Medicaid providers and suppliers (including nursing facilities, hospitals, dialysis facilities and all other provider types covered by the rule) while there are court-ordered injunctions in place prohibiting enforcement of this provision.

Please see the full memo or https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and-memos-states-and/vaccination-regulation-enforcement-rule-imposing-vaccine-requirement-health-care-staff-medicare-and for details.

CMS Memo QSO 20-39-NH: Nursing Home Visitation – COVID-19 (Revised 11-12-2021)

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CMS has issued updated visitation guidance for visitation in nursing homes. The new guidance includes that visitation is now allowed for all residents at all times. DHSS will be updating its guidance as well and it will be consistent with the CMS guidance. Long-term care facilities certified for Medicare and Medicaid are required to follow the CMS memo. All long-term care communities (SNF, ICF, ALF and RCF) may utilize the CMS guidance until the DHSS guidance is updated.

Please see the full memo at https://www.cms.gov/files/document/qso-20-39-nh-revised.pdf.

COVID-19 Health Care Staff Vaccination IFC-6: Presentation Slides and Video

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A message from CMS

Thank you for your interest in in the COVID-19 Omnibus Vaccine Rule (IFC-6). Last week’s stakeholder call had a limit of 10,000 participants and we exceeded that number. Please accept our apologies.

CMS has posted the presentation slides and a recording of the stakeholder call for your convenience.

To view the slides, visit https://www.cms.gov/files/document/covid-19-health-care-staff-vaccination-ifc-6-national-stakeholder-call-slides.pdf.

To view the video, visit https://www.youtube.com/watch?v=xHA0zY1aC-Y.

In addition to the resources above, CMS has prepared a frequently asked questions document, available here: https://www.cms.gov/files/document/cms-omnibus-staff-vax-requirements-2021.pdf.

Our next stakeholder call will be held on:
Wednesday, November 10, 2021
3:30 – 4:30 PM EST
To register in advance, visit https://cms.zoomgov.com/webinar/register/WN_bCsmBuXfTnOCK0owoQVHvg.

After registering, you will receive a confirmation email containing information about joining the webinar.

*Please note we can only accommodate 10,000 participants so register early to guarantee your participation.*

Again, thank you for your interest in this important topic. We look forward to working with you and, appreciate your commitment to the safety of your staff and patients.

New QIPMO Newsletter – November 2021

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The Quality Improvement Program for Missouri (QIPMO) has published MDS Tips and Clinical Pearls (Volume 9, Issue 1).

In this issue:

  • 5-Star Staff
  • Tube Feeding Monitoring
  • Giving Thanks
  • Accounts Payable
  • Red Light, Orange Light, Yellow Light, Blue?
  • More Than a Thousand Words

Please visit QIPMO’s website here for this and other previous newsletters.

Abbott BinaxNOW Expiration Dates

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You can access the most information related to Abbott of BinaxNOW tests that have been authorized to have their expiration dates extended by accessing information directly from Abbott’s website.  Use the instructions to see the letter and listing of BinaxNOW™ COVID-19 Ag Card lots which qualify for this expiry extension. Please pay close attention to the lot number, currently labeled kit expiry, and new kit expiry date. The image below helps you to locate the lot number of the Abbott BinaxNOW test kits.

FAQs for NHSN users that report weekly COVID-19 Vaccination Data for LTC Facilities

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November 2, 2021: FAQs for NHSN users that report weekly COVID-19 Vaccination Data for Long-term Care Facilities

CDC will host a webinar to review recent updates to the National Healthcare Safety Network (NHSN) weekly COVID-19 vaccination data reporting modules. This webinar will focus on addressing some of the frequently asked questions (FAQs) from facilities, reviewing data entry issues, and highlighting helpful training materials and resources.

Join the listen-only webinar to hear comprehensive responses to your FAQs based on the updates made to these modules. Thank you for submitting data to the NHSN weekly COVID-19 Vaccination Module for long-term care facilities.

Please use the link below to register:

Topic: FAQs for NHSN users that report weekly COVID-19 Vaccination Data for Long-term Care Facilities
Date: Tuesday, November 02, 2021
Time: 2:30 PM EST
Register in advance for this webinar:
https://cdc.zoomgov.com/webinar/register/WN_RI1J5TBRTmu0HiRKMALAtw

After registering, you will receive a confirmation email containing information about joining the webinar.

CMS Memo QSO-20-38-NH: Interim Final Rule (IFC), CMS-3401-IFC, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency related to Long-Term Care (LTC) Facility Testing Requirements

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Long-Term Care (LTC) Facility COVID-19 Testing Requirements (QSO 20-38-NH, revised 9/10/2021)

Please read the memo carefully. CMS has revised testing requirements for nursing homes including testing of symptomatic residents and staff, and routine testing of staff. Two major changes are:

  • Facilities now have two options to conduct outbreak testing, through either a contact tracing or broad-based testing approach. See Table 1.
  • Routine staff testing is now based on the facility’s county level of community transmission instead of county test positivity rate. The link to determine county level of community transmission is in the memo. The frequency of testing has also been updated. See Table 2.

 

Table 1: Testing Summary

Testing Trigger

Staff

Residents

Symptomatic individual identified

Staff, vaccinated and unvaccinated, with signs or symptoms must be tested.

Residents, vaccinated and unvaccinated, with signs or symptoms must be tested.

Newly identified COVID- 19 positive staff or resident in a facility that can identify close contacts

Test all staff, vaccinated and   unvaccinated, that had a higher-risk exposure with a COVID-19 positive individual.

Test all residents, vaccinated and unvaccinated, that had close contact with a COVID-19 positive individual.

Newly identified COVID- 19 positive staff or resident in a facility that is unable to identify close contacts

Test all staff, vaccinated and unvaccinated, facility-wide or at a group level if staff are assigned to a specific location where the new case occurred (e.g., unit, floor, or other specific area(s) of the facility).

Test all residents, vaccinated and unvaccinated, facility-wide or at a group level (e.g., unit, floor, or other specific area(s) of the facility).

Routine testing

According to Table 2 below

Not generally recommended

 

Table 2: Routine Testing Intervals by County COVID-19 Level of Community Transmission

Level of COVID-19 Community

Transmission

Minimum Testing Frequency of

Unvaccinated Staff+

Low (blue)

Not recommended

Moderate (yellow)

Once a week*

Substantial (orange)

Twice a week*

High (red)

Twice a week*

+Vaccinated staff do not need to be routinely tested.

 

Please see the full memo for complete details at https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and-memos-states-and/interim-final-rule-ifc-cms-3401-ifc-additional-policy-and-regulatory-revisions-response-covid-19-0.

MHCA Virtual Convention 2021

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October 1-31, 2021: MHCA Virtual Convention

For those who attended the convention in-person but missed an education session, you now have access to any missed sessions as well. Therefore, all of the facilities that registered for the in-person Convention are automatically enrolled in the Virtual Convention! Please note – each facility registered for the Virtual Convention can allow an unlimited number of attendees from your registered facility to participate in the education sessions offered virtually.

If you could not attend the in-person Convention, you can register now for the Virtual Convention. Once the Virtual Convention begins, the education sessions will be available 24/7 and run through October 31.

Pioneer Network Hot Topics – Culture Change in Action

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October 21, 2021: Someone Just for Me: Recognizing a Critical Role for Volunteers
Speaker: Dr. Paul Falkowski, Ph.D., Gerontologist, Author, Speaker, Educator

Long before COVID-19, professionals working in long-term care knew about the devastating effects of social isolation. Now because of COVID-19, social isolation has become an all too familiar term to the general population. We heard reports of people passing due to being disconnected from their families and friends during the past year. But what about the people who did not have family or friends?

Creating and sustaining intimate relationships takes time and commitment. In this session, you will learn the critical components for creating “authentic” relationships. You will learn how to recruit, screen for, and train a cadre of volunteers, who go on to become “companions” or, as one older woman observed, “…someone that is here just for me.” We’ll look at the transformational power volunteers like these can have on the people you serve, the people serving them, the volunteers themselves, and your surrounding community.

Monoclonal Antibody Infusion Medication Information

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There has been a significant change in the ordering process for monoclonal antibody infusion medications. If you are currently utilizing these medications, please review the attached notice and plan on attending the webinar tomorrow. Also attached is information on reporting usage through the Teletracking system. Reporting through this system is highly encouraged as the usage reported will determine future amounts allocated to the state.

 Status Update re: Monoclonal Antibody (mAb) Infusion Medication Ordering:

Missouri Department of Health and Senior Services (DHSS) was notified by U. S. Department of Health and Human Services (HHS) yesterday, September 14, 2021, that effective immediately the states are responsible to review and approve all monoclonal antibody medication orders. This includes orders for REGEN-COV (casirivimab and imdevimab) and the Eli Lilly cocktail of bamlanivimab/etesevimab through AmeriSource Bergen. This was DHSS’ first notification of this change. We had no prior information to allow for planning, development of platforms for ordering/approvals or procedures, or messaging. Thus, all of this is occurring currently and as quickly as possible. Information on this change is still forthcoming from HHS, thus we may have process implementation delays at the state level as a result.

mAb Request Process Implementation and Timeline:

DHSS will host a webinar to introduce the state’s new mAb request process, details are below:

Friday, September 17, 2021

10:30-11:30 a.m.

Join from the meeting link

https://stateofmo.webex.com/stateofmo/j.php?MTID=mcb62b527fff05778bd574584e06c8b6d
 

Join by meeting number

Meeting number (access code): 2462 582 1044

Meeting password: pcGjudFE679
 

Tap to join from a mobile device (attendees only)
+1-650-479-3207,,24625821044## Call-in toll number (US/Canada)
+1-312-535-8110,,24625821044## United States Toll (Chicago)

NHSN COVID-19 Vaccination Data Reporting – Additional Dose Questions

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Recently, NHSN launched two new questions in the weekly COVID-19 vaccination module. During the reporting week of 8/23/2021 through 8/29/2021, facilities began reporting on the number of individuals eligible to receive additional or booster doses of COVID-19 vaccine (question #4) and the number of individuals who received additional or booster doses (question #5).

Facilities should refer to the CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States to determine which individuals are eligible to receive additional or booster doses. According to the current guidance, an additional mRNA COVID-19 vaccine dose is recommended for moderately to severely immunocompromised people after they completed an initial 2-dose mRNA vaccine series. Therefore, facilities should include the following individuals in question #4 as eligible to receive an additional dose of the COVID-19 vaccine:

  1. Received an initial complete 2-dose mRNA COVID-19 vaccine series at this facility or elsewhere since December 2020 (question 2); AND
  2. Eligible to receive an additional or booster dose of the COVID-19 vaccine, per CDC guidance noted above.

In response to questions, NHSN received about reporting additional COVID-19 vaccine dose or booster data, scenario examples are provided below to assist in determining how to respond to these new questions.

  • Facility A is unsure how to determine who in their facility is considered eligible for an additional dose or booster at this time.

Facilities should refer to the CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States to determine individuals who are eligible to receive additional doses or boosters after receiving an initial completed vaccination series. For more information about COVID-19 vaccine indications for individuals who are immunocompromised, please see the FAQs at: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/immunocompromised.html.

  • Facility B has a staff member who only received dose 1 of the Moderna COVID-19 vaccine. However, this staff member expressed an interest in receiving an additional dose of the vaccine.

The facility would not include the staff member in questions 4 and 5 on the data collection form since he/she did not complete an initial COVID-19 vaccination series.

  • Facility C cannot determine if an individual is eligible for an additional dose at this time because they do not know the individual’s health status to determine if they are immunocompromised.

If a facility is unable to determine whether an individual is considered eligible to receive an additional dose or booster at this time, the individual should not be reported in question 4 or question 5 on the data collection form.

For reporting through the NHSN COVID-19 vaccination modules, assume these two staff members were eligible to have received an additional dose of the COVID-19 vaccine. Include these two staff members in question 4 and question 5 of the data collection form.

  • After reviewing the current Interim Clinical Considerations for Use of COVID-19 Vaccines, facility E does not have any individuals who are eligible to receive an additional dose or booster of COVID-19 vaccine.

This facility should report that zero individuals are eligible to receive an additional dose or booster of COVID-19 vaccine in question 4. The new question 4 and question 5 on the data collection form are required fields. A value must be entered for each of these questions for the form to be saved successfully. A zero (“0”) should be entered for question #4 and a zero “0” entered for question #5 (select any manufacturer from the dropdown). This will allow the form to save successfully.

Updated resources, including training materials, data collection forms, table of instructions documents, and other supporting materials are available on the following webpages:

Weekly HCP & Resident COVID-19 Vaccination | LTCF | NHSN | CDC
Weekly HCP COVID-19 Vaccination | HPS | NHSN | CDC
Weekly Patient COVID-19 Vaccination | Dialysis | NHSN | CDC

Frequently asked questions (FAQ) have also been updated (please see questions 23-27) and can be accessed using this link: https://www.cdc.gov/nhsn/hps/weekly-covid-vac/faqs.html.

We appreciate your efforts to report these critical data accurately and completely. We encourage updates to previously entered data as needed. If you have any questions or concerns, please let us know. As always, questions can be sent to NHSN@cdc.gov using ‘COVID-19 vaccination’ in the subject line of the message.

COVID Testing Information

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State Orders for Abbott BinaxNOW Tests

Missouri is experiencing constrained supplies of the BinaxNOW COVID antigen test cards. Thus, effective September 9, 2021, DHSS is implementing a revised BinaxNOW test ordering cadence in order to conserve supply and assure the optimum availability of BinaxNOW COVID antigen tests for all users. Until further notice, please order no more than two weeks supply of BinaxNOW tests for use by your facility or organization. If our supply allows larger quantities to be ordered, we will modify this process accordingly at that time and notify all users. https://health.mo.gov/living/healthcondiseases/communicable/novel-coronavirus/testing-resources.php

To Reinstate Direct Shipments of Abbott BinaxNOW from the Federal government:

Providers should email their facility information, shipping address and the BinaxNOW delivery Point of Contact for the facility and request to be added back onto the direct shipment list to Binax.Team@hhs.gov. Please be aware reinstatement depends upon available supply of tests to the Federal government and this can take several weeks to begin receiving shipments again.

Reimbursement for OUTBREAK Testing

A reminder that in order to furnish immediate aid and relief in response to the state of emergency due to the spread of COVID-19, the State of Missouri has made some funds from the Coronavirus Relief Fund available to Missouri Long Term Care facilities with COVID-19 Outbreaks. These funds are available to Long-Term Care facilities that experience an outbreak (one or more positive cases) and are conducting base-line facility testing and some immediate follow-up testing in order to contain outbreaks. For more information: https://apps.dss.mo.gov/LongTermCareCovid19Invoices/.

LTC Bed Availability Portal Reminder

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Reminder: After submitting the initial survey, a confirmation email will be provided for a link to update your survey each day (instead of submitting a new survey). Submitting a new survey results in multiple surveys showing on the map with different bed numbers. This makes it difficult to know which totals are current. Please use the link emailed after the initial submission to edit facility bed availability. Please do not submit an “initial” submission more than once. If information does not change from day to day, the submitter can simply update the date and submit – the prior day’s information will populate.

The survey information will populate an accompanying dashboard that will be available to hospitals to use as a tool in finding placement for those patients who would be best served in a long-term care setting. This dashboard may be accessed at https://mophep.maps.arcgis.com/apps/opsdashboard/index.html#/f1e0745f93fe46b482d8ff4585f821bf. To view instructions on utilizing the dashboard, click on ‘Instructions’ under the map for information.

DHSS COVID-19 Vaccination Booster Doses Survey

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The Department of Health and Senior Services is planning for the upcoming approval of booster COVID-19 vaccination doses and long-term care facilities will be a priority. The federal pharmacy program used to administer first and second doses will not be available, so it is important to ensure long-term care facilities receive the needed support for the administration of booster doses. We are asking for your feedback regarding your facility’s readiness to administer booster doses. https://www.surveymonkey.com/r/VTT296F

For those SNFs (Medicaid/ Medicare certified) that already completed the NHSN survey, we already have your results no further action is needed.

For questions regarding this survey, please contact Lana Hudanick at Lana.hudanick@heatlh.mo.gov or 314-982-8260. Please reply by September 15, 2021.

COVID-19 After Action Report (AAR) Survey – Deadline Extended

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The deadline to complete the DHSS COVID-19 After Action Report (AAR) Survey has been extended to Friday, September 3, 2021. Your assistance in helping us gather this important data is greatly appreciated. Please feel free to share the link with your state, regional, and local partners in the following categories:

  • Public Health/LPHA
  • Hospital
  • EMS
  • Emergency Management
  • Behavioral Health
  • Healthcare Coalition Leadership
  • State Agency Partners

https://survey123.arcgis.com/share/d20126ad3a05496d87dbf3b4b65d7592?portalUrl=https://mophep.maps.arcgis.com

Please let us know if you have any questions or difficulties with the survey.
John Whitaker – John.Whitaker@health.mo.gov
Brendan Bagby – Brendan.Bagby@health.mo.gov

CDC Health Advisory/DHSS Health Alert

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Please see the CDC Health Advisory entitled, “Rapid Increase in Ivermectin Prescriptions and Reports of Severe Illness Associated with Use of Products Containing Ivermectin to Prevent or Treat COVID-19” and the DHSS Health Alert “Self-medication with Ivermectin for the Treatment and Prevention of COVID-19.”

Should you have any questions, please contact the Missouri Department of Health and Senior Services’ Bureau of Communicable Disease Control and Prevention at 573-751-6113.

Onsite Clinical and On the Job Training for Students Entering Health Care (Nurses, Nurse Aides, Therapy)

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SLCR has received questions regarding whether or not Skilled Nursing Facilities can be a clinical or on the job training sight for students entering health care fields. The quick answer is YES! Long-term care facilities can use the guidance from CMS memo QSO 20-39-NH and DHSS visitation guidance as a way to say “YES” to hosting schools who are training our next workforce in long-term care. Students can be considered health care workers who are not employees of the facility but provide direct care to the facility’s residents. They can be permitted to come into the facility as long as they are not subject to a work exclusion due to an exposure to COVID-19 or showing signs or symptoms of COVID-19 after being screened. Facilities should work with the schools to ensure they are aware of infection control policies and procedures and to whom questions can be addressed.

The most recent visitation guidance from CMS and DHSS can be accessed on our website: https://health.mo.gov/living/healthcondiseases/communicable/novel-coronavirus/professionals.php.

For questions related to this, please contact Angela.Duvall@health.mo.gov.

Updated Standing Orders and Affidavits for Third Dose of COVID-19 Vaccine

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Following recent announcements from the US Food and Drug Administration and the Centers for Disease Control and Prevention, certain immunocompromised individuals can begin receiving third doses of COVID-19 vaccine in Missouri.

A third dose of the PfizerNBioTech or Moderna vaccines may be administered to moderately to severely immunocompromised people due to a medical condition or combination of immunosuppressive medication or treatments including but not limited to the following:

  • Immunocompromised due to solid organ transplant and taking immune suppressing medications
  • Immunocompromised due to active treatment for solid tumor and hematologic malignancies
  • Immune compromised due to Receipt of CAR-T cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy)
  • Moderate to severe primary immunodeficiency (eg., DiGeorge, Wiskott-Aldrich Syndromes)
  • Immunocompromised due to Advanced or untreated HIV infection
  • Immunocompromised due to “Active treatment with high-dose corticosteroids or other drugs that may suppress immune response: high dose corticosteroids (ie.,≥ 20 mg prednisone or equivalent per day), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blocker or other biologic agents that are immunosuppressive or immunomodulatory”

Individuals who do not meet the criteria for “moderately to severely immunocompromised” do not need a third dose at this time.

In line with federal guidelines, Missouri will use a self-attestation model for people who are moderately to severely immunocompromised. Individuals will not be required to provide documentation of their health status, and they can get third doses at all venues where first and second doses are available.

This guidance does not apply to those who received the Janssen/Johnson & Johnson vaccine. For people who received either Pfizer-BioNTech or Moderna’s COVID-19 vaccine series, a third dose of the same mRNA vaccine should be used. A person should not receive more than three mRNA vaccine doses at this time. If the mRNA vaccine product given for the first two doses is not available or is unknown, either mRNA COVID-19 vaccine product may be administered. Individuals should wait at least 28 days between their second and third doses.

Announcements from federal health officials came after the analysis of studies demonstrating that immunosuppressed people are more likely to get severely ill from COVID-19, are at higher risk for prolonged infection, are more likely to transmit the virus, and experience lower vaccine effectiveness.

Additional information regarding this guidance can be found on the CDC website at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html.

Interim clinical considerations for use of COVID-19 vaccines can be found at https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html.

Missouri’s revised standing orders can be found at https://health.mo.gov/living/healthcondiseases/communicable/novel-coronavirus/statewide-orders.php.

LTC Updates and Materials

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Due to the recent increase in COVID activity in skilled nursing facilities as well as outbreaks in assisted living communities, here are some resources that may be of interest to your members and ask that you share this material as widely as possible.

Below, you will find a fact sheet and social media graphics that reiterates important infection prevention strategies, including promoting COVID-19 vaccinations and continuing to wear a mask. This factsheet can be emailed to staff or used as a poster to reinforce the urgent actions CDC is asking of all healthcare providers and staff in long-term care facilities.

Additionally, there are also two slide decks that were reviewed on our partner call last week. The first slide deck summarizes the urgent action CDC recommends for protecting residents and staff from COVID infections as well as information about how CDC is working to ensure vaccine access for long-term care facilities. The second slide deck provides additional information about monoclonal antibody treatment.

LTC Infection Control Delta Factsheet
2021-08-11 LTC MAb update Slide Show
NH partner summary_21-08

 

Finally, below are links to existing web resources. Please share these as well.

Healthcare Staffing Contract with SLS Health

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The Department of Health and Senior Services has entered into a contract with SLS Health to assist with staffing needs for healthcare facilities, including long-term care facilities. The contract will allow skilled nursing, intermediate care, assisted living or residential care facilities to access the contract to secure healthcare staffing according to a firm, fixed rate. Payment for the staffing costs will be borne by the respective facility. Please see below attachments for additional information about the contract, how to access staffing resources, and applicable rates.

Missouri’s COVID-19 Healthcare Augmentation LTC slides
Attachment B

Revocation of NIOSH Certification

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As of August 13, 2021, any Shanghai Dasheng Health Products Manufacture Co., Ltd. respirator with a NIOSH approval label containing a revoked approval number is no longer NIOSH-approved and cannot be manufactured, assembled, sold, or distributed.

See the link below to find the approval numbers of the respirators that have been de-certified. The approval number starts with TC-84A. If you can’t find this number on the respirator or its packaging, it was never NIOSH approved in the first place and shouldn’t be used, but if it has any of the listed TC numbers in the link below on the respirator itself or its packaging, you should discontinue use immediately and remove from use any that have been distributed.

https://www.cdc.gov/niosh/npptl/resources/pressrel/letters/respprotect/CA-2021-1038.html