VDH COVID-19 Monoclonal Antibody and Therapeutics Bi-Weekly Updates

Reporting Therapeutics Usage & Inventory

• Sites that do not comply with the reporting requirements by 2/22/2022 will NOT receive additional allocations of therapeutics
• Reporting of doses used last week and on-hand to the U.S. Healthcare COVID-19 Portal (i.e., TeleTracking) is required weekly on Wednesdays by 11:59PM ET for Bam/Ete, REGEN-COV, and Sotrovimab
• VDH has published a job aid for reporting into the U.S. Healthcare COVID-19 Portal, which can be accessed here
• Reporting of doses used and on-hand to HPoP is required daily by 11:59 PM ET for Evusheld, Paxlovid, and Molnupiravir
  
• VDH is currently developing a job aid for reporting into the Health Partner Order Portal (HPOP)

Bam/Ete and REGEN-COV Monoclonal Antibody Information (HHS Update 1/26/2022)

• The return of Bam/Ete and REGEN-COV is not recommended; any returned product has to be destroyed
• The COVID-19 environment remains dynamic
• Existing monoclonal antibody products (e.g., Bam/Ete, REGEN-COV) may be effective against future variants

Therapeutics Storage (HHS Update 1/26/2022)

• If you have storage concerns or challenges:
• Consider transferring products to another location/site in your region or health system
• If your facility does not have the appropriate storage space and you would like to transfer product, please contact covid19therapeutics@vdh.virginia.gov
• If product must be returned:
• For Bam/Ete, see The Lilly Return Goods Procedure; detailed guidance can be found at: https://www.lillytrade.com/
• For REGEN-COV, call 844-734-6643
• Note: Reconstituted (diluted) product SHOULD NOT be returned and should be treated as waste per your facility’s SOP

Reminder: CMS Code for Outpatient Intravenous Veklury (Remdesivir) Use

• Following a recent statement from the National Institutes of Health (NIH) COVID-19 Treatment Guidelines Panel regarding therapies for COVID-19 Omicron variant, CMS created HCPCS code J0248 for the antiviral medication Veklury (Remdesivir) when administered in outpatient setting
• Medicare Administrative Contractors (MACs) determine Medicare coverage when no national coverage determination exists, including when providers use FDA-approved drugs for indications other than what is on the approved label
• MACs will determine Medicare coverage for HCPCS code J0248 for Veklury (Remdesivir) administered in the outpatient setting
• See CMS COVID-19 Provider Toolkit for additional information
• Reimbursement information is still pending with the Virginia MACs
• The VDH COVID-19 Therapeutics team will update these guidelines as soon as more information is available

Updates to the VDH COVID-19 Treatment Locator Tool

• Please find the locator tool here: COVID-19 Treatment Locator
• If you are not listed on the Locator Tool and provide appointments to the public, please email covid19therapeutics@vdh.virginia.gov and your information will be added

Upcoming COVID-19 Therapeutics Webinar Details

• Registration links:
• Wednesday, 02/09/2022 from 12-1PM
• Wednesday, 02/16/2022 from 12-1PM
• Wednesday, 02/23/2022 from 12-1PM