COVID-19 VACCINE INFORMATION

Everyone Ages 5 and Older Now Eligible for Updated COVID-19 Boosters

The Wisconsin Department of Health Services (DHS) is urging Wisconsinites to get an updated COVID-19 booster vaccination and their annual flu shot ahead of the upcoming holiday season. People can safely get their COVID-19 vaccines and other vaccines, including flu, at the same time. Everyone ages 5 and older is now eligible for an updated COVID-19 booster.  

These updated boosters target the original strain of COVID-19, as well as the BA.4 and BA.5 Omicron subvariants. The updated boosters are recommended as a single (1) dose for people 5 and older who have received their primary COVID-19 vaccine series and have not received a COVID-19 vaccine dose in the last two months. People 5 and older are eligible to receive the updated Pfizer COVID-19 booster, and those 6 and older are eligible to receive the updated Moderna COVID-19 booster. For all age groups, these updated boosters replace the original boosters. 

COVID-19 vaccination is still available with no out-of-pocket cost. Anyone can schedule an appointment for the vaccine. Pharmacies, health centers, and clinics are continuing to make appointments available as their booster doses arrive over the next several weeks. Vaccination sites may choose to provide vaccines to specific age groups. People are encouraged to check with their primary care provider, local or Tribal health department or clinics, or visit vaccines.gov to find information about vaccination sites and the ages served. 

For those 6 months and older who have not yet received their primary series of COVID-19 vaccines, it is never too late to get vaccinated. For free, confidential support finding health care and community resources near you, dial 211. 

COVID-19: Novavax Vaccine, Adjuvanted — New Codes

The FDA authorized emergency use of the Novavax COVID-19 vaccine, Adjuvanted for the prevention of COVID-19 disease in patients 18 years and older.

CMS issued 3 new CPT codes effective July 13, 2022:

Code 91304 for vaccine product:

• Long descriptor: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, recombinant spike protein nanoparticle, saponin-based adjuvant, preservative free, 5 mcg/0.5 mL dosage, for intramuscular use
• Short descriptor: SARSCOV2 VAC 5MCG/0.5ML IM

Code 0041A for vaccine administration, first dose:

• Long descriptor: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, recombinant spike protein nanoparticle, saponin-based adjuvant, preservative free, 5 mcg/0.5 mL dosage; first dose
• Short descriptor: ADM SARSCOV2 5MCG/0.5ML 1ST

Code 0042A for vaccine administration, second dose:

• Long descriptor: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, recombinant spike protein nanoparticle, saponin-based adjuvant, preservative free, 5 mcg/0.5 mL dosage; second dose
• Short descriptor: ADM SARSCOV2 5MCG/0.5ML 2ND

Visit the COVID-19 Vaccine Provider Toolkit for more information, and get the most current list of billing codes, payment allowances, and effective dates. Note: You may need to refresh your browser if you recently visited this webpage.

FDA NEWS RELEASE

Coronavirus (COVID-19) Update: FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations

New Prescribing Authority Could Improve Access for Some Patients at High Risk for Severe COVID-19

·       Share

·       Tweet

·       Email

For Immediate Release: July 06, 2022

Today, the U.S. Food and Drug Administration revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir), to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid. 

“The FDA recognizes the important role pharmacists have played and continue to play in combatting this pandemic,” said Patrizia Cavazzoni, M.D., director for the FDA’s Center for Drug Evaluation and Research. “Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19.” 

When testing positive for COVID-19, patients should first consider seeking care from their regular health care provider or locating a Test-to-Treat site in their area. While this action allows state-licensed pharmacists to prescribe Paxlovid with certain limitations as described below, community pharmacies not already participating as a Test-to-Treat site can decide if or how they will offer this service to patients.  

Patients who have tested positive for COVID-19 and are seeking to determine their eligibility for receiving Paxlovid at locations where prescribing by state-licensed pharmacists is available should bring the following information to ensure that the state-licensed pharmacist has sufficient information to determine their eligibility to receive Paxlovid:

• Electronic or printed health records less than 12 months old, including the most recent reports of laboratory blood work for the state-licensed pharmacist to review for kidney or liver problems. State-licensed pharmacists could also receive this information through a consult with the patient’s health care provider.
• A list of all medications they are taking, including over-the-counter medications so the state-licensed pharmacist can screen for drugs with potentially serious interactions with Paxlovid.

Under the limitations outlined in the authorization, the state-licensed pharmacist should refer patients for clinical evaluation with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs, if any of the following apply:

• Sufficient information is not available to assess renal and hepatic function.
• Sufficient information is not available to assess for a potential drug interaction.
• Modification of other medications is needed due to a potential drug interaction.
• Paxlovid is not an appropriate therapeutic option based on the current Fact Sheet for Healthcare Providers or due to potential drug interactions for which recommended monitoring would not be feasible.

Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 viral testing, who are at high risk for progression to severe COVID-19, including hospitalization or death. Patients in the authorized population who report a positive home test result from a rapid antigen diagnostic test, or a positive PCR test, to their provider are eligible for Paxlovid under the EUA. Confirmation of a positive home rapid antigen diagnostic test with additional direct SARS-CoV-2 viral testing, such as a PCR, is not required. Antibody tests are not considered to be direct SARS-CoV-2 viral tests.

COVID-19: FDA Authorizes Pharmacists to Prescribe PAXLOVID with Certain Limits

The FDA issued an emergency use authorization (EUA) for PAXLOVID (nirmatrelvir co-packaged with ritonavir) for the treatment of mild-to-moderate COVID-19 in certain adults and pediatric patients at high risk for progression to severe COVID-19, including hospitalization or death. On July 6, the FDA revised the EUA to let pharmacists prescribe and dispense PAXLOVID to eligible patients without seeing a doctor or other clinician.

More Information:

New COVID-19 Treatments Add-On Payment (NCTAP) webpage (Note: You may need to refresh your browser if you recently visited this webpage)
Fact Sheet for Health Care Providers: EUA for PAXLOVID: information about the limits and conditions

Related Information

Paxlovid EUA Letter of Authorization
Frequently Asked Questions on the Emergency Use Authorization for Paxlovid
FDA Updates on Paxlovid for Health Care Providers
Emergency Use Authorization: Drugs and Non-Vaccine Biological Products
Coronavirus Disease (COVID-19)
Coronavirus Treatment Acceleration Program (CTAP)
Test to Treat Locator
COVID-19 Therapeutics Locator

Long COVID: Use ICD-10 Code U09.9

For a post COVID-19 condition, unspecified, like Long COVID, use code DX U09.9. Add other codes for conditions related to the COVID-19 infection, like R50.9 for fever.

For a current COVID-19 infection, use code DX U07.1. Don’t use code DX U09.9. 

For a current COVID-19 infection and conditions from a previous COVID-19 infection, use code U09.9 with code DX U07.1. Add other codes for conditions related to the COVID-19 infection, like R06.02 for shortness of breath.

For more information, see pages 30-31 of ICD-10-CM Official Guidelines for Coding and Reporting: Fiscal Year 2022 (PDF).

COVID-19: Pfizer-BioNTech Vaccines for Children as Young as 6 Months — New Codes

On June 17, 2022, the FDA amended the Pfizer-BioNTech COVID-19 vaccine emergency use authorization (PDF) to authorize use for all patients 6 months – 4 years old. Get important vial and dosing information. CMS issued new CPT codes effective June 17, 2022:

Code 91308 for vaccine product:

• Long descriptor: Severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, mRNALNP, spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation, for intramuscular use
• Short descriptor: SARSCOV2 VAC 3 MCG TRS-SUCR

Code 0081A for vaccine administration, first dose:

• Long descriptor: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, mRNALNP, spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; first dose
• Short descriptor: ADM SARSCV2 3MCG TRS-SUCR 1

Code: 0082A for vaccine administration, second dose:

• Long descriptor: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, mRNALNP, spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; second dose
• Short descriptor: ADM SARSCV2 3MCG TRS-SUCR 2

Code 0083A for vaccine administration, third dose:

• Long descriptor: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, mRNALNP, spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; third dose
• Short descriptor: ADM SARSCV2 3MCG TRS-SUCR 3

Visit the COVID-19 Vaccine Provider Toolkit for more information, and get the most current list of billing codes, payment allowances, and effective dates. Note: you may need to refresh your browser if you recently visited this webpage.

COVID-19: Moderna Vaccines for Children as Young as 6 Months — New Codes

The FDA amended the Moderna COVID-19 vaccine emergency use authorization (PDF) to authorize use for all patients 6 months – 17 years old.

CMS issued 7 new CPT codes effective June 17, 2022:

Code 91311 for vaccine product:

• Long descriptor: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 25 mcg/0.25 mL dosage, for intramuscular use
• Short descriptor: SARSCOV2 VAC 25MCG/0.25ML IM

Code 0111A for vaccine administration, first dose:

• Long descriptor: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 25 mcg/0.25 mL dosage; first dose
• Short descriptor: ADM SARSCOV2 25MCG/0.25ML1ST

Code 0112A for vaccine administration, second dose:

• Long descriptor: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 25 mcg/0.25 mL dosage; second dose
• Short descriptor: ADM SARSCOV2 25MCG/0.25ML2ND

Code 0113A for vaccine administration, third dose:

• Long descriptor: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 25 mcg/0.25 mL dosage; third dose
• Short descriptor: ADM SARSCOV2 25MCG/0.25ML3RD

Code 0091A for vaccine administration, first dose:

• Long descriptor: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 50 mcg/0.5 mL dosage; first dose, when administered to individuals 6 through 11 years
• Short descriptor: ADM SARSCOV2 50 MCG/.5 ML1ST

Code 0092A for vaccine administration, second dose:

• Long descriptor: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 50 mcg/0.5 mL dosage; second dose, when administered to individuals 6 through 11 years
• Short descriptor: ADM SARSCOV2 50 MCG/.5 ML2ND

Code 0093A for vaccine administration, third dose:

• Long descriptor: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 50 mcg/0.5 mL dosage; third dose, when administered to individuals 6 through 11 years
• Short descriptor: ADM SARSCOV2 50 MCG/.5 ML3RD

Visit the COVID-19 Vaccine Provider Toolkit for more information, and get the most current list of billing codes, payment allowances, and effective dates. Note: You may need to refresh your browser if you recently visited this webpage.

Wisconsin has Adequate Supply of Oral and IV Antiviral Therapies for COVID-19 to Offer Treatment to Patients at Risk for Severe Disease

Key Points

• Oral antiviral medications for the treatment of COVID-19 are now widely available across Wisconsin. Consult the DHS therapeutics locator map to find pharmacies with supply on hand.
• Providers should encourage symptomatic patients who may be at risk for severe disease to test as soon as possible and seek treatment if diagnosed with COVID-19.
• Paxlovid and Verkuly (remdesivir) are the preferred medications for treatment of non-hospitalized patients with COVID-19 based on recent guidance the National Institutes of Health.
• Health systems are encouraged to develop protocols for identifying COVID-positive patients who are at risk for severe disease and referring them for treatment. Integrating pharmacy consultation into treatment pathways can assist prescribers with selecting appropriate medications and managing drug-drug interactions.

Background:

In December 2021, Paxlovid and Lagevrio (molnupiravir) received emergency use authorization (EUA) from the Food and Drug Administration for the treatment of patients with mild-to-moderate COVID-19 who are at risk for progression to severe disease. Supplies of these medications were initially very limited, and DHS encouraged healthcare providers to utilize NIH patient prioritization tiers. Since that time, availability of these medications has increased significantly across Wisconsin.

Prompt diagnosis is critical to ensuring patients are treated within the window of eligibility. Providers should encourage symptomatic patients who may be at risk for severe disease to test as soon as possible and seek treatment if diagnosed with COVID-19. CDC has compiled a list of medical conditions associated with higher risk for severe COVID-19 that can be consulted when considering patients for treatment. 

Availability of Oral Antiviral Medications:

Since January, a total of 12,740 patient courses of Paxlovid and 2,888 courses of Lagevrio have been distributed to healthcare facilities in Wisconsin. As of April 27, only 23% of Paxlovid and 6% of Lagevrio courses have been dispensed to patients. Supplies are now sufficient to treat patients with mild-to-moderate COVID-19 who are at risk for progression to severe disease.

Oral antivirals are available at pharmacies across the state, including many community pharmacies, selected Walgreens and Walmart pharmacies, and all CVS locations. Healthcare providers can consult the DHS therapeutics page to find pharmacies with medications on hand.

NIH Recommendations for Treatment of Non-hospitalized Adults with COVID-19

The following treatments are recommended by the National Institutes of Health for non-hospitalized patients with COVID-19. Consult the NIH website for the latest information, as treatment guidelines are continually revised.

Preferred Therapies: In order of preference

• Paxlovid (nirmatrelvir/ritonavir) 300mg/100mg orally twice daily for 5 days, initiated within 5 days of symptom onset. Dosage adjustment required for renal impairment.
• Verkuly (remdesivir) 200 mg IV on Day 1, followed by RDV 100 mg IV once daily on Days 2 and 3, initiated within 7 days of symptom onset
• Alternative Therapies: For use only when preferred therapies are not available. Listed in alphabetical order
• Bebtelovimab 175 mg as a single IV injection, initiated within 7 days of symptoms onset
• Lagevrio (molnupiravir) 800 mg PO twice daily for 5 days, initiated within 5 days of symptom onset

Treatment Protocols for COVID-19 Therapeutics

Health systems are encouraged to develop treatment protocols for patients with mild-to-moderate COVID-19 who are at risk for progression to severe disease. Integration of pharmacy consultation into treatment pathways may assist prescribers in selecting the appropriate medications and managing drug-drug interactions. The US Department of Health and Human Services has developed a treatment algorithm which can be used a starting point for protocol development.

Additional information:

DHS Therapeutics Map

Paxlovid (ritonavir-boosted nirmatrelvir) Fact Sheet for Healthcare Providers

Lagevrio (molnupiravir) Fact Sheet for Healthcare Providers

Verkuly (remdesivir) Fact Sheet for healthcare providers

CDC: Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19

NIH Therapeutic Management of Nonhospitalized Adults With COVID-19

HHS COVID Therapeutics Decision Aid

COVID-19 Monoclonal Antibodies: Revised Emergency Use Authorization for EVUSHELD
On February 24, the FDA revised the emergency use authorization for tixagevimab co-packaged with cilgavimab (EVUSHELD™) to change the initial dose for the authorized use as pre-exposure prophylaxis of COVID-19 in certain adults and pediatric patients. For more information about dosage and administration, including information about dosing for patients who got the original lower dose, review the fact sheet (ZIP).

CMS created new code, Q0221, effective February 24:

Long Descriptor: Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adults and pediatric individuals (12 years of age and older weighing at least 40kg) with no known sars-cov-2 exposure, who either have moderate to severely compromised immune systems or for whom vaccination with any available covid-19 vaccine is not recommended due to a history of severe adverse reaction to a covid-19 vaccine(s) and/or covid-19 vaccine component(s), 600 mg
Short Descriptor: Tixagev and cilgav, 600mg
Use the existing administration codes — M0220 and M0221.

Visit the COVID-19 Monoclonal Antibodies webpage for more information. Note: you may need to refresh your browser if you recently visited this webpage.

COVID-19 Vaccine Codes: Pfizer Pre-Diluted Vaccine for Patients Ages 12+ & Third Dose for Immunocompromised Patients Ages 5–11

On January 3, the FDA:

Authorized an additional pre-diluted formulation (gray cap) for patients 12 years and older
Amended the Pfizer-BioNTech COVID-19 vaccine (PDF) emergency use authorization to allow for third pediatric doses (orange cap) for 5–11-year-old solid organ transplant patients or patients with a similar level of immunocompromise

Get the most current list of billing codes, payment allowances, and effective dates.

More Information:

COVID-19 provider toolkit
Vaccine payment rates
How to bill to administer vaccines

COVID-19 Vaccine & Monoclonal Antibody Products: Changes for MA Plan Claims Started January 1

If you vaccinate or administer monoclonal antibody treatment to patients enrolled in Medicare Advantage (MA) plans on or after January 1, 2022, submit claims to the MA Plan. Original Medicare won’t pay these claims.

More Information:

• Medicare Billing for COVID-19 Vaccine Shot Administration
• Monoclonal Antibody COVID-19 Infusion

Encouraging COVID-19 Vaccination Among Pregnant People

Dear Partner/Stakeholder,

I am contacting you today to ask that you to continue to be a strong and vocal advocate in helping encourage pregnant and recently pregnant people to get the COVID-19 vaccine. Vaccination is safe and effective for pregnant and recently pregnant people, and it is strongly recommended by the Centers for Disease Control and Prevention (CDC).

If unvaccinated, pregnant and recently pregnant people are at high risk to get severely ill from COVID-19. Getting them vaccinated now is especially important as COVID-19 cases rise and with likely increased exposure during the holiday season.

As a healthcare provider or strong advocate of this group, you are the most trusted source for COVID-19 information. We urge you to give a strong recommendation for COVID-19 vaccination to every patient and ensure there is vaccine on hand at every point in your patients’ care journeys to provide easy access to vaccination when people are ready for it.

Please see the following resources to support your conversations and provide additional information regarding the vaccine, fertility and pregnancy:

DHS Fact Sheet: COVID-19 Vaccine: Fertility and Pregnancy
DHS webpage: COVID-19: Vaccine, Fertility, and Pregnancy
DHS video: Vaccine and Pregnancy
CDC webpage: COVID-19 Vaccines for People Who Would Like to Have a Baby
CDC webpage: COVID-19 Vaccines While Pregnant or Breastfeeding

Thank you for your dedication to the safety of those in your care.

Wisconsin Department of Health Services

Confronting COVID-19 Vaccine Misinformation
View shareable resources and the Advisory from the U.S. Surgeon General about COVID-19 misinformation.
View Resources >

Clinical Considerations: Myocarditis and Pericarditis after Receipt of mRNA COVID-19 Vaccines Among Adolescents and Young Adults
Since April 2021, increased cases of myocarditis and pericarditis have been reported in the United States after mRNA COVID-19 vaccination (Pfizer-BioNTech and Moderna), particularly in adolescents and young adults. There has not been a similar reporting pattern observed after receipt of the Janssen COVID-19 Vaccine (Johnson & Johnson).
Read More

Monoclonal antibody treatments, available under U.S. Food and Drug Administration (FDA) Emergency Use Authorizations (EUAs), are used to treat individuals with mild to moderate COVID-19 who are at high risk of developing severe disease and may decrease the risk of hospitalization and death in high-risk patients. Recently, the FDA expanded the use of these therapeutics to include a broader cross-section of individuals at risk.  
 
There are new informational resources on the CombatCOVID.hhs.gov website that you may find helpful. They include:

• the latest clinical evidence and scientific resources and references
• practical information on billing/reimbursement; including CMS announcement of an increase in the Medicare payment rate for monoclonal antibodies to treat beneficiaries with COVID-19
• an informational flyer for patients (can be printed as 8x11 or 11 x17)
• a variety of short provider videos about their experience with mAbs treatment
• Click here to access these new resources.
• Replay AAFP/HHS Webinar on COVID-19 Monoclonal Antibodies

Coronavirus variants renamed as Greek alphabet letters
The World Health Organization has renamed coronavirus variants using letters of the Greek alphabet to simplify naming without stigmatizing countries where they were detected. The variant first discovered in the UK becomes Alpha, the variant detected in South Africa is Beta, the variant found in Brazil is Gamma, and the variant first seen in India will be called Delta. Full Story

CMS would like to make you aware that the federally supported website that makes it easier for individuals to access COVID-19 vaccines is now live. Vaccines.gov – powered by the trusted VaccineFinder brand – is available in English and Spanish, with high accessibility standard, and will help connect Americans with locations offering vaccines near them. In addition to the website, people in the U.S. are also now able to utilize a text message service, available in both English and Spanish. People can text their ZIP code to 438829 (GETVAX) and 822862 (VACUNA) to find three locations nearby that have vaccines available.

Vaccines.gov is meant to complement the number of state and pharmacy websites that have been successfully connecting many Americans with vaccinations, by providing a unified federal resource for Americans to use no matter where they are. 

In addition to the website and text messaging service, the National COVID-19 Vaccination Assistance Hotline is now available to help those who prefer to get information by phone on where to get a vaccine. Call 1-800-232-0233 to find a location near you.