WSHA COVID-19 Meeting with State Leaders - December 13, 2021 This meeting is being recorded

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WSHA COVID-19 Meeting with State Leaders - December 13, 2021 This meeting is being recorded
WSHA COVID-19 Meeting with State Leaders
December 13, 2021

                    This meeting is being recorded
WSHA COVID-19 Meeting with State Leaders - December 13, 2021 This meeting is being recorded
Agenda
• Reflections from Peer Meetings – Cassie Sauer & Taya Briley, WSHA

• Epi Report & COVID-19 Update – Dr. Bob Lutz, DOH

• Difficult to Discharge – Zosia Stanley, WSHA

• mAb Update – Ezra Stark, DOH

• Vaccine Update – SheAnne Allen, DOH

• COVID-19 and the 2022 Legislative Session – Ashlen Strong & Cassie Sauer, WSHA
WSHA COVID-19 Meeting with State Leaders - December 13, 2021 This meeting is being recorded
Reflections from Peer Meetings
Cassie Sauer, WSHA
Taya Briley, WSHA
WSHA COVID-19 Meeting with State Leaders - December 13, 2021 This meeting is being recorded
Epi Report & COVID-19 Update
Dr. Bob Lutz, DOH
WSHA COVID-19 Meeting with State Leaders - December 13, 2021 This meeting is being recorded
WSHA LEADERSHIP 12.13.2021
Bob Lutz, MD, MPH
WSHA COVID-19 Meeting with State Leaders - December 13, 2021 This meeting is being recorded
https://www.nytimes.com/interactive/2021/us/covid-cases.html?name=styln-
coronavirus&region=TOP_BANNER&block=storyline_menu_recirc&action=click&pgtype=LegacyCollection&variant=0_Control&is_new
=false
WSHA COVID-19 Meeting with State Leaders - December 13, 2021 This meeting is being recorded
https://www.nytimes.com/interactive/2021/us/covid-cases.html?name=styln-
coronavirus&region=TOP_BANNER&block=storyline_menu_recirc&action=click&pgtype=LegacyCollection&variant=0_Control&is_new=false
WSHA COVID-19 Meeting with State Leaders - December 13, 2021 This meeting is being recorded
https://www.nytimes.com/interactive/2021/us/covid-cases.html?name=styln-
coronavirus&region=TOP_BANNER&block=storyline_menu_recirc&action=click&pgtype=LegacyCollection&variant=0_Control&is_new=false
WSHA COVID-19 Meeting with State Leaders - December 13, 2021 This meeting is being recorded
https://www.nytimes.com/interactive/2021/us/covid-cases.html?name=styln-
coronavirus&region=TOP_BANNER&block=storyline_menu_recirc&action=click&pgtype=LegacyCollection&variant=0_Control&is_new=false
WSHA COVID-19 Meeting with State Leaders - December 13, 2021 This meeting is being recorded
0.83
0.32%
1/312
Statewide trends
Week 48 November 28 – December 04, 2021

                                  During week 48, 0.4% of specimens tested by WHO/NREVSS collaborating
                                  laboratories in Washington were positive for influenza.
                                  https://www.doh.wa.gov/Portals/1/Documents/5100/420-100-FluUpdate.pdf
total cases (confirmed & probable) –
788,877; Δ9961; 1423/d (1345/d)

total hospitalizations – 43,599; Δ382; ~55/d

total deaths – 9535; Δ155

*IR – 244/100,000/2wks
(280/100,000/2wks)
*as of 12.09.2021
7d day avg. – 1571 (1349)
244/100,000/2wks (280)

         data as of 12.09.2021
Data as of 12.09.2021
Data as of 12.09.2021
data as of 12.09.2021
Eastern WA

             7d rolling avg. – 406 (366)
             272/100,000/2wks (369)

                     data as of 12.09.2021
Eastern WA

             data as of 12.09.2021
Eastern WA

             data as of 12.09.2021
Western WA

             7 d rolling avg. – 1168 (959)
             235/100,000/2wks (281)

                         data as of 12.09.2021
Western WA

             data as of 12.09.2021
Western WA

             data as of 12.09.2021
healthcare
7d rolling avg. – 92 (99)

7d rolling avg.-120

                         data as of 12.09.2021
20.6
                         7d rolling avg. – 92 (99)

7d rolling avg.-120

                         data as of 12.09.2021
25%

      data as of 12.09.2021
data as of 12.09.2021
7d rolling avg. – 92 (99)

7d rolling avg.-120

                         data as of 12.09.2021
7d rolling avg. – 92 (99)

7d rolling avg.-120

                         data as of 12.09.2021
WA Health – 11.27.2021
WA Health – 12.03.2021
WA Health – 12.12.2021
vaccinations
https://www.gisaid.org/hcov19-variants/
https://theconversation.com/south-africa-early-data-suggest-omicron-is-more-transmissible-but-less-severe-173517
Phylogenetic tree of Nextstrain Clade 21K (Omicron)
transmission advantage

transmission advantage -
  increased transmissibility
 increased immune escape
might see different patterns of immune escape in
different settings
Omicron appears to be rapidly out-competing
Delta in South Africa

                    Washington State Department of Health | 43
transmission advantage

Number of
sequences

% of
sequences
                                                                                       Delta              Omicron

                                                       Time in weeks (2021)
    South Africa National Institute for Communicable Diseases: Tracking SARS-CoV-2 variants, 12/8/21 report.
    https://www.nicd.ac.za/diseases-a-z-index/disease-index-covid-19/sars-cov-2-genomic-surveillance-update/
                                   Washington State Department of Health | 44
virulence

 potential reduced clinical severity in South Africa -
    true decrease in virulence
    testing/bias, confounding
    time lag for hospitalizations/deaths
    protection from severe illness/death - immunity from prior
    infection or vaccination

South African Medical Research Council, Tshwane District Omicron Variant Patient Profile - Early Features. 12/4/21.
https://www.samrc.ac.za/news/tshwane-district-omicron-variant-patient-profile-early-features
Twitter, John Burn-Murdoch, 12/8/21. https://twitter.com/jburnmurdoch/status/1468310555844874257

                                                  Washington State Department of Health | 45
immune escape - two lines of evidence

risk of reinfection appears to be increasing in South Africa*

  early results from neutralization assays - decreased neutralization of
  Omicron by sera for various combinations of vaccines and prior infection

  better neutralization with prior infection + vaccination or 3 mRNA doses

 *MedRxiv, Pulliam et al., Increased risk of SARS-CoV-2 reinfection associated with emergence of the Omicron variant in South Africa, 12/2/21.
 https://www.medrxiv.org/content/10.1101/2021.11.11.21266068v2
 tSee “Immune escape references” slide for remaining references

                                                       Washington State Department of Health | 46
immune escape - neutralization results

Pfizer and BioNTech, 12/8/21. https://investors.biontech.de/static-files/47b4131a-0545-4a0b-a353-49b3a1d01789

                             Washington State Department of Health | 47
impact on diagnostics

almost all NAAT and antigen tests will continue to
detect Omicron
  one PCR test will fail to detect Omicron entirely (Tide
  Laboratories DTPM COVID-19 RT-PCR Test)
some PCR tests will have S-gene target failure (SGTF),
which can help identify possible Omicron cases
  one lineage of Omicron does not have SGTF - absence of SGTF
  will not rule out Omicron

           FDA, SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests, 12/7/21. https://www.fda.gov/medical-
           devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests

                                 Washington State Department of Health | 48
prioritizing Omicron for sequencing

DOH - proactively request specimens for all cases
marked with international travel
   query cases with travel information in WDRS
   view in CREST to identify cases
DOH has contacted all laboratories known to run the
TaqPath assay and asked them to submit S-dropout
specimens to PHL
working with LHJs to request specimens for cases epi-
linked to confirmed Omicron cases

                    Washington State Department of Health | 49
Washington State Department of Health is committed to providing customers with forms
 and publications in appropriate alternate formats. Requests can be made by calling
        800-525-0127 or by email at civil.rights@doh.wa.gov. TTY users dial 711.
Difficult to Discharge
Zosia Stanley, WSHA
Difficult to discharge/Long length of stay patients

• Increasing capacity concerns due directly to difficult to place patients

• Impacting nonurgent procedures and exacerbating workforce challenges

• WSHA pursuing legislative priorities to address top barriers and establish sustainable
  solutions:
    – Consent to long term care placement
    – DSHS staffing increase
    – Fund public guardianships for low-income patients
    – Maintain LTC incentives for patients discharging from hospitals
    – Maintain capacity for COVID+ SNF units
    – Presumptive eligibility for Medicaid LTC
    – Increase Medicaid rates for LTC facilities
mAb Update
Ezra Stark, DOH
COVID-19 Therapeutics distribution
Updates for Washington Hospitals

Ezra Stark – DOH Medical Countermeasures Coordinator
December 12th, 2021
mAb Allocations for Washington State

      Date         HHS Allocation to   Casirivimab   Bamlanivimab        Sotrovimab       EVESHELD
                     Washington        /Imdevimab     /Etesevimab
    Copyright Notice
    ©2020, Washington State
November 15th,        3,460
                            Hospital Association.
                                        1,740
                                                  All Rights Reserved.
                                                          1,030             690               0
2021
November 29th,          2,664            1,464           1,200               0                0
2021
December 13th,          2,234            1,224           1,010               0        1,080(anticipated)
2021

                 Notes:
                 - 2-week allocation cycles
                 - Recent decrease in REGEN-COV availability(EUA expanded)
                 - Steady availability of bamlanivimab/etesevimab(EUA expanded)
                 - Sotrovimab not available in state allocation
                 - EVUSHELD allocation available this week(EUA authorized)
Challenges/Issues:
 Copyright Notice
 ©2020, Washington State Hospital Association. All Rights Reserved.

                                                                      Monoclonal
                                                                      Antibody
                                                                      Administration
                                                                      Sites that have
                                                                      requested
                                                                      shipment in WA
Copyright Notice
©2020, Washington State Hospital Association. All Rights Reserved.
Copyright Notice
   mAb  updates
    ©2020, Washington State Hospital Association. All Rights Reserved.

Casirivimab / Imdevimab(REGEN-COV)

Expanded storage requirements to allow to kept kept at room temperature for up to 30 days when shielded from light.

Bamlanivimab / Etesevimab

Expanded the Emergency Use Authorization (EUA) for bamlanivimab and etesevimab administered together to
include pediatric patients under the age of 12, including neonates (infants
Copyright Notice
   New  Therapeutics Update - EVUSHELD
    ©2020, Washington State Hospital Association. All Rights Reserved.

On December 8, 2021, AstraZeneca’s EVUSHELD, a combination of two anti-SARS-COV-2 monoclonal antibodies
(tixagevimab/cilgavimab), received an EUA from the FDA.
(https://www.fda.gov/media/154701/download)

mAb for pre-exposure prophylaxis in individuals aged 12 and older (weighing ≥ 40 kg) who are either unable to mount
an adequate immune response to COVID-19 vaccination or are unable to get a COVID-19 vaccine due to concern for
severe adverse reactions.

Current authorization is for redosing every six months. The product is administrated via intramuscular injection.

 EVUSHELD is supplied as a single carton containing 1 single-dose vial of tixagevimab injection and 1 single-dose
vial of cilgavimab injection.

Twenty-four cartons are packaged in a case and the case is the minimum order. EVUSHELD is stored as a
refrigerated product at 2° to 8°C.
Copyright Notice
  New  Therapeutics Update - Molnupiravir
   ©2020, Washington State Hospital Association. All Rights Reserved.

The Antimicrobial Drugs Advisory Committee (AMDAC) met on 30 November and recommended Merck’s Molnupiravir
oral antiviral for use by a narrow 13-10 vote.

The FDA has not formally considered the AMDAC’s recommendation for use under an EUA but is expected to do so
on 17 December.

Molnupiravir is packaged in unit-of-use bottles, 40 capsules to taken 8 per day over 5 days and intended to treat
outpatients with mild to moderate COVID-19.

Storage is normal room temperature, 20° to 25°C.

Molnupiravir could be ready to order via Healthcare Partner Order Portal the week of 20 December.
CopyrightAllocation
  Antiviral  Notice    Prioritization
    ©2020, Washington State Hospital Association. All Rights Reserved.

Tier 1A
Sites (or partnerships) that can fulfill all test to treat requirements in a high SVI/region with higher cases per 100k.
Tier 1B
Sites (or partnerships) that can fulfill all test to treat requirements in a region with higher cases per 100k.
Tier 1C
Sites (or partnerships) that can fulfill all test to treat requirements in high SVI counties that do not have high cases per
100k.
Tier 2
Sites that cannot fulfill all test to treat requirements, however, are able to administer or dispense treatment based on
prescription or recommendation from a healthcare provider. This tier will be used when allocation amounts are larger.

“test to treat requirements” are defined by a site that can provide COVID-19 testing, patient evaluation and
recommendation, provide prescription for treatment, and administer or dispense treatment on its own or through
partnerships.
“Test to Treatment”
  Copyright Notice
  ©2020, Washington State Hospital Association. All Rights Reserved.

DOH will continue to identify suitable sites for distribution based on
capabilities that can expedite test-to-treatment.
   Sites that can:
       Administer/confirm either molecular/antigen POC COVID-19 test
       Prescribe medication
       Dispense medication
There is an anticipated 5-day window between symptom onset and when an
antiviral course should begin.

May be an additional requirement to test for pregnancy in some cases.
Copyright
  FederalNotice
           Retail Pharmacy Partnerships
 ©2020, Washington State Hospital Association. All Rights Reserved.
Goal:
Work with retail pharmacy partners to
provide oral antiviral dispensing
capabilities statewide. Retail
pharmacies as complementary to
health care partners, not primary

Partners: Walgreens / Rite-Aid / CVS

Locations: 1-3 sites per region initially

Capability: Able to
test/prescribe/dispense

Benefit: Will allow wider, more
equitable availability statewide
Copyright Notice
     Other distribution partners
    ©2020, Washington State Hospital Association. All Rights Reserved.
•    Regional hospitals
•    Local clinics
•    Independent pharmacies
•    Health Departments
Orientation for new Healthcare Partner Order
             Portal (HPOP) sites

             Training/Orientation are held via virtual training
              on Tuesdays at 9AM through the reminder of
Questions?   2021.

             Upcoming Dates:
             December 14th
             December 21st
             Please contact mcm@doh.wa.gov to register.
Vaccine Update
SheAnne Allen, DOH
68
Vaccinations by age group

Source https://www.doh.wa.gov/Emergencies/COVID19/DataDashboard (12/13/2021)
1 year
celebration
of vaccine
rollout
What’s coming next?
                   (Things we are waiting for…)

                   Moderna for adolescents

                   Moderna for children (6-11 y)

                   Moderna full BLA

                   Smaller Pfizer/Comirnaty package size

                   J & J for adolescents

                   J & J for children (6-11 y)

                   J & J full BLA

                   Boosters for kids (?)

                   Vaccine recommendations 6 months+ (?)

Washington State Department of Health | 71
• Booster doses of the
Booster Doses   Pfizer-BioNTech vaccine are
                now available for teens ages
                16 and 17.
                • Everyone 16 and older is
                recommended to get a
                booster dose:
                   •   Six months after
                       receiving the
                       Moderna or Pfizer
                       vaccine, or
                   •   Two months after
                       receiving the
                       Johnson & Johnson
                       vaccine.
Pfizer
• Pfizer 450 –no longer available
• Pfizer has submitted an expiration date extension for peds.
• Comirnaty.
   •   300 minimum dose order
   •   12+ (12-15 covered under EUA)
   •   Will come in the Peds shipper
   •   Same storage as Peds
   •   No more diluent
   •   Same volume of dose (.3ml)
   •   Will see in threshold in mid-December. Start planning. The initial lots will be
       short dated, so providers should not be stocking up.
Washington State Department of Health | 74
Moderna Ordering

• Half Doses
    • If you need 200 booster doses, when you order in the IIS you only need to order 100
• Ordering Cap
• There is a lot of Moderna out in the field expiring in the next few months so make
  sure you are rotating stock and changing your ordering patterns accordingly
    • Some Moderna is short-dated to expire in January so order as needed.
    • Vaccine Advertisement page

                      Washington State Department of Health | 75
Additional Updates
Supply

• Additional access points
• Update vaccine locator
• Manage inventory- expiring doses

HRSA

• HRSA is not really doing distribution anymore. They are pushing them back to the
  Jurisdictions to order both Peds and adult vaccine.

Pfizer 2-4 year old

• Feb- Mar
FEMA Opportunity
• Dec 15- Jan 20
• Thurston & King County
• Fixed sites
• Mobile vaccine teams

• Inslee announced FEMA mobile
  COVID-19 vaccination unit will
  be coming to Western
  Washington.
COVID Vaccine Counseling Billing
         Providers who counsel patients about COVID-19 vaccine
         information and availability can bill using the codes below:
              Established patient office visit series: 99211 - 99215
              Preventive medicine counseling, approx. 15 minutes: 99401(new
              as of 12/3/21)
              Telephone evaluation codes: 99441 - 99443
              In the scenario the provider is already seeing the patient for
              another reason, and counseling for COVID-19 vaccination
              increases the time spent with the patient, the provider may
              account for this additional time by choosing the appropriate
              E/M level

         Nurses and medical assistants who counsel patients about COVID-
         19 vaccine information and availability can bill using CPT® code
         99211
     Policy retroactive to dates of service beginning on 6/22/21
Vaccine Counseling Emergency Order
 Conditions for coverage:
    Consultation is by an in-network medical provider (does not include pharmacy
    services providers)

    Provider checks patient’s vaccination status and asks patient to confirm patient
    isn’t already vaccinated. Provider has established relationship with patient

    Provider/patient discussion is contemporaneous, either in-person or via voice. If
    audio-only, patient must consent to health plan being billed for the service

    Cap of two billings per patient

    Bill using diagnosis code Z71.89 and CPT code 99401, 99441 or 98966
COVID Vaccine
Administration
Billing
COVID-19 and the 2022 Legislative Session
Ashlen Strong, WSHA
Cassie Sauer, WSHA
Thank you for joining us today
Copyright Notice
©2021, Washington State Hospital Association. All Rights Reserved.
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