COVID-19 Therapeutics Provider Weekly News Digest - Jan. 17

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COVID-19 Therapeutics Provider Weekly News Digest

Jan. 17, 2022

13th Edition


HHS COVID-19 Therapeutics Locator

The U.S. Department of Health and Human Services (HHS) has developed a therapeutics locator which displays the locations that have inventory of newly authorized COVID-19 therapeutics: Evusheld, Molnupiravir, and Paxlovid. Providers may use this locator to identify where they can send a prescription for the oral medications or refer a patient for administration of Evusheld.


HCPCS Code for Outpatient Use of Remdesivir

Centers for Medicare and Medicaid Services (CMS) created Healthcare Common Procedure Coding System (HCPCS) Code J0248 for the Veklury (remdesivir) antiviral medication when administered in an outpatient setting. The code is available for use by all payers.

Medicare Administrative Contractors (MACs) determine Medicare coverage when there is no national coverage determination, including when providers use FDA-approved drugs for indications other than what is on approved label. MACs will determine Medicare coverage for HCPCS code J0248 for remdesivir administered in an outpatient setting.

Providers can access the CMS COVID-19 Provider Toolkit for more information.


Created vs. Exported Status in VAOS

Upon requesting an allocation of COVID-19 therapeutics in the Vaccine Allocation & Ordering System (VAOS), your order request will be marked as “created” until DSHS exports the request, at which point it will be moved to “exported” status.

Providers who need to make changes to existing therapeutics order requests in VAOS are encouraged to edit existing order requests rather than create a second or third request during the same ordering cycle. Orders may be edited as long as they are still under “created” status; once moved to “exported” status, an order request may no longer be edited.

Submitting one order request per cycle will help ensure that the provider’s order request is addressed in the most efficient fashion.

For details on editing existing therapeutics order requests in VAOS, please visit the View & Edit Service Requests section the COVID-19 Therapeutics Allocation Request job aid. For questions, please contact us by email at therapeutics@dshs.texas.gov or by phone at (833) 832-7068 (Option 0).

Created vs. Exported Status in VAOS

Reminder: Sotrovimab TeleTracking Reporting Requirements

Beginning January 19, 2022, providers who report directly in HHS TeleTracking will be able to report Sotrovimab.


Reminder: BAM/ETE and REGEN-COV Not Effective Against Omicron Variant

Currently, the CDC estimates that Texas and surrounding states (Region 6) have greater than 98% prevalence of the Omicron variant. Bamlanivimab/Etesevimab (BAM/ETE) and REGEN-COV (REG) are NOT effective in the treatment of patients infected with the Omicron variant. All shipments of bamlanivimab/etesevimab (BAM/ETE) and REGEN-COV (REG) have therefore been paused by US Department of Health and Human Services, and both therapeutics products have been temporarily removed from the Vaccine Allocation & Ordering System (VAOS). Sotrovimab remains effective against all variants of concern, including Omicron, but is currently in limited supply.

Providers requesting BAM/ETE and REG as therapeutic options should ensure that there is laboratory evidence that the patient is NOT infected by the Omicron variant.  If a provider would like to request a quantity of BAM/ETE and REG to have on hand to treat a patient that is NOT infected by the Omicron variant according to laboratory evidence, please contact DSHS at therapeutics@dshs.texas.gov.

For more information, please review DSHS’ Jan. 3rd email, titled “DSHS Update on Monoclonal Antibodies and the Omicron Variant.”


Reminder: Paxlovid, Molnupiravir, Evusheld Distribution and Use

DSHS has been allocated limited quantities of oral medications Paxlovid and Molnupiravir for treatment of high-risk patients with mild/moderate COVID-19 infection and limited quantities of Evusheld, a monoclonal antibody for pre-exposure prophylaxis for COVID-19 in people who are immunocompromised and who are not expected to mount an adequate immune response to the COVID-19 vaccine. (Note: Evusheld is not a substitute for vaccination in individuals who have been recommended to be vaccinated but can be used in an individual with a history of a severe allergic reaction to a COVID-19 vaccine and who cannot complete the vaccination series.)

DSHS has distributed its allocation of these three therapeutics; due to limited supply, they are not available for ordering in VAOS at this time. Healthcare providers can refer to the US HHS Locator to view the facilities that will have supply of these medications for patients.

For more information on Paxlovid, view the Health Care Provider Fact Sheet and FDA FAQ document for Paxlovid.

For more information on Molnupiravir, view the Health Care Provider Fact Sheet and FDA FAQ document for Molnupiravir.

For more information on EVUSHELD, view the Health Care Provider Fact Sheet and FDA FAQ document for Evusheld.

Please review DSHS’ Dec. 29th email communication, titled “Recently Authorized Therapeutics for COVID-19,” for further details on these three therapeutics products.


Reminder: COVID-19 Therapeutics Ordering Timeline

The deadline for placing an order request in this cycle for COVID-19 monoclonal antibody (mAb) therapeutics is Thursday at 5:00 p.m. Central Time

Allocation considerations are based on weekly allocation cycles. A new allocation cycle begins every Friday. For your request to be considered for the upcoming cycle, your order must be placed in VAOS no later than Thursday, January 20th, by 5:00 p.m. Central Time. Any requests received after Thursday at 5:00 p.m. will be considered for the following allocation cycle.

Please note that if you are not allotted any therapeutics in a given allocation cycle, you must submit another order request the following cycle; requests are not “carried over” from one week to the next.


Expert Tip: Don’t Dig Through Your Email – Review Past Therapeutics Communications in One Convenient Location

DSHS’ new webpage for COVID-19 therapeutics providers not only houses important therapeutics product information, ordering guides, FAQs, and contact information, it is also the one-stop-shop for all past therapeutics communications. Rather than searching your inbox for DSHS’ therapeutics-related emails, simply navigate to the News & Updates section of the webpage to access PDF versions of emails dating back to December 2021.



Provider Resources

Access trainings, VAOS job aids, and other provider resources by visiting the Information for COVID-19 Therapeutics Providers page

Review answers to commonly asked provider questions in the FAQ for Therapeutics Providers.

View the COVID-19 Therapeutics Allocation Request instructional video to learn about the ordering process in VAOS for COVID-19 monoclonal antibody therapeutics.

 

EUAs & Fact Sheets for COVID-19 Monoclonal Antibody (mAb) Therapeutics

Please select the links below to view the EUAs, fact sheets, and other resources associated with each COVID-19 therapeutic.

 

Contact Us

If you have therapeutics-related questions, or if a member of your facility would like to be added to or removed from this newsletter’s mailing list, please reach out by email at therapeutics@dshs.texas.gov or by phone at (833) 832-7068, Option 0.