Learn more about the latest on COVID-19 here.

SPIKEVAX is the mRNA vaccine from Moderna that is helping to address the COVID-19 pandemic. SPIKEVAX is now FDA-approved and can continue to help protect your adult patients from COVID-19. Please find additional information about prescribing and administering SPIKEVAX to patients below.

Click here to view information for physicians about SPIKEVAX »

INDICATION
SPIKEVAX (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

IMPORTANT SAFETY INFORMATION
Contraindications
Do not administer SPIKEVAX to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of SPIKEVAX.

Warnings and Precautions

• Management of Acute Allergic Reactions: Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of SPIKEVAX.
• Myocarditis and Pericarditis: Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 18 through 24 years of age.
• Syncope (fainting): May occur in association with administration of injectable vaccines, including SPIKEVAX. Procedures should be in place to avoid injury from fainting.
• Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to SPIKEVAX.
• Limitations of Vaccine Effectiveness: SPIKEVAX may not protect all vaccine recipients.

Adverse Reactions
In study participants 18 through 64 years of age, the most commonly reported (≥10%) adverse reactions were pain at the injection site (93.3%), fatigue (71.9%), headache (68.7%), myalgia (64.8%), chills (49.7%), arthralgia (48.6%), nausea/vomiting (25.7%), axillary swelling/tenderness (22.2%), fever (17.3%), swelling at the injection site (15.4%), and erythema at the injection site (10.5%).

In study participants 65 years of age and older, the most commonly reported (≥10%) adverse reactions following any dose were pain at the injection site (88.3%), fatigue (64.8%), headache (53.3%), myalgia (51.8%), arthralgia (40.2%), chills (32.7%), nausea/vomiting (15.0%), swelling at the injection site (13.0%), and axillary swelling/tenderness (12.7%).

Reporting Adverse Events and Vaccine Administration Errors
The vaccination provider is responsible for mandatory reporting of certain adverse events to the Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov or by calling 1-800-822-7967.

See the full prescribing information for SPIKEVAX »

For information regarding authorized emergency uses of the Moderna COVID-19 Vaccine, please read the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information »

To be eligible for treatment, patients must meet the following criteria:

• be 12 years of age or older;
• weigh at least 40 kilograms (about 88 pounds);
• present positive for COVID-19;
• be at a high-risk for progressing to a severe case of COVID-19, including hospitalization or death; and
• not be eligible for alternative COVID-19 treatment options approved or authorized by the FDA due to a lack of access or clinical inaptitude.

Bebtelovimab is not approved for patients who are "hospitalized due to COVID-19 or require oxygen therapy due to COVID-19," and like other mAb therapies, "may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation."

The following information was shared by the FDA in a recent press release about bebtelovimab: 

• Bebtelovimab works by binding to the spike protein of the virus that causes COVID-19, similar to other monoclonal antibodies that have been authorized for the treatment of high-risk patients with mild to moderate COVID-19 and shown a benefit in reducing the risk of hospitalization or death.
• The FDA is carefully monitoring circulating viral variants and their sensitivity to authorized monoclonal antibodies, including bebtelovimab. Laboratory testing showed that bebtelovimab retains activity against both the omicron variant and the BA.2 omicron subvariant.
• The placebo-controlled portion of the trial enrolled 380 low-risk patients (i.e., patients without risk factors for progression to severe COVID-19 illness). Patients in this part of the trial were randomized to receive a single infusion of bebtelovimab alone, bebtelovimab with other monoclonal antibodies or a placebo. Treatment with bebtelovimab resulted in a reduction in time to sustained symptom resolution compared to placebo. Reduction in viral load relative to placebo was also seen on Day 5 after treatment.
• In another part of the trial involving mostly high-risk individuals (i.e. patients with risk factors for progression to severe COVID-19 illness), 150 patients were randomized to receive a single infusion of bebtelovimab alone or a single infusion of bebtelovimab with other monoclonal antibodies. An additional 176 high-risk patients received bebtelovimab with other monoclonal antibodies in an open-label treatment arm.
• The rates of COVID-19 related hospitalization and death through Day 29 seen in those who received bebtelovimab alone or with other monoclonal antibodies were generally lower than the placebo rate reported in prior trials of other monoclonal antibodies in high risk patients. Conclusions are limited as these data are from different trials that were conducted when different viral variants were circulating and baseline risk factors varied.
• Clinical data were similar for bebtelovimab alone as compared to the combination of bebtelovimab with other monoclonal antibodies.
• Possible side effects of bebtelovimab include itching, rash, infusion-related reactions, nausea and vomiting.
• Serious and unexpected adverse events including hypersensitivity, anaphylaxis and infusion-related reactions have been observed with other SARS-CoV2 monoclonal antibodies and could occur with bebtelovimab. In addition, clinical worsening following administration of other SARS-CoV-2 monoclonal antibody treatment has been reported and therefore is possible with bebtelovimab. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19.

Learn more about bebtelovimab here »

The agency advised that cloth masks do not offer the same level of protection as respirators (specialized filtering masks), specifically, N95 and KN95 respirators. Properly fitted nonsurgical N95 and KN95 respirators provide the highest level of protection against COVID-19; individuals should feel free to choose these types of respirators, but surgical N95 masks should remain reserved for use in healthcare settings.

The CDC emphasized the fact that the effectiveness of a mask heavily depends on whether it is well-fitted to the individual's face and worn correctly. Regardless of the type of mask, the agency says "it should provide a good fit (i.e., fitting closely on the face without any gaps along the edges or around the nose) and be comfortable enough when worn properly (covering your nose and mouth) so that you can keep it on when you need to."

The agency also outlined specific circumstances in which it is best to opt for a nonsurgical N95 or KN95 respirator:

• When caring for someone who is sick with COVID-19.
• If you are at increased risk for severe illness, for example, people who are immunocompromised, older adults, and people with certain underlying medical conditions.
• When working at a job where you interact with large numbers of the public, especially when not everyone is consistently wearing a mask. For example, bus drivers and grocery store workers.
• When riding on planes, buses, trains, or other forms of public transportation*, especially if it is for a long period of time on crowded conveyances.
• When physical distancing is not possible or when you are in crowded indoor or outdoor public settings.
• If you are not up to date on COVID-19 vaccinations.

Head here to learn more about the CDC's masking guidance »

The following bulletin was share with the Arizona Medical Association (ArMA): 

The U.S. Food & Drug Administration (FDA) has authorized a further extension of the shelf life for the Janssen COVID-19 vaccine from 4.5 months to 6 months. The shelf life had been previously extended from 3 months on June 10, 2021. The decision is based on data from ongoing stability assessment studies, which have demonstrated that the vaccine is stable at 6 months when refrigerated at temperatures of 36 – 46 degrees Fahrenheit (2 – 8 degrees Celsius).

We continue to work with the U.S. government and health authorities to support the use of our vaccine, which plays an important role in combatting the pandemic, including among those who wish to be fully vaccinated with one shot.

Prior to discarding any doses of the Janssen COVID-19 vaccine, we recommend vaccine providers check the expiration dates using one of the following methods outlined in the attached resource, and below:

• Visit www.vaxcheck.jnj and input the lot number
  
• Scan the Quick Response (QR) code on the carton using a mobile device camera
• Call (US Toll-Free) 1-800-565-4008 or (US Toll) 1-908-455-9922

You can also view a video detailing the process of checking the Janssen COVID-19 Vaccine expiry information by clicking here https://www.janssencovid19vaccine.com/hcp/check-expiration.html.

The Janssen vaccine has not been approved or licensed by the FDA, but has been authorized by FDA through an Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019 (COVID 19) in individuals 18 years of age and older. The emergency use of this product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the medical product under Section 564(b)(1) of the FD&C Act, unless the declaration is terminated or authorization revoked sooner.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Do not administer the Janssen COVID-19 vaccine to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Janssen COVID-19 Vaccine.

WARNINGS AND PRECAUTIONS

• Management of Acute Allergic Reactions: Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Janssen COVID-19 vaccine.
• Monitor Janssen COVID-19 vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).
• Thrombosis with Thrombocytopenia: Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of thrombosis involving the cerebral venous sinuses and other sites (including but not limited to the large blood vessels of the abdomen and the veins of the lower extremities) combined with thrombocytopenia and with onset of symptoms approximately one to two weeks after vaccination. The reporting rate of thrombosis with thrombocytopenia reported following the administration of the Janssen COVID-19 Vaccine has been highest in females ages 18 through 49 years; some cases have been fatal. The clinical course of these events shares features with autoimmune heparin-induced thrombocytopenia. Specific risk factors for thrombosis with thrombocytopenia following administration of the Janssen COVID-19 Vaccine and the level of potential excess risk due to vaccination are under investigation. Based on currently available evidence, a causal relationship between thrombosis with thrombocytopenia and the Janssen COVID-19 Vaccine is plausible. Healthcare professionals should be alert to the signs and symptoms of thrombosis with thrombocytopenia in individuals who receive the Janssen COVID-19 Vaccine. In individuals with suspected thrombosis with thrombocytopenia following administration of the Janssen COVID-19 Vaccine, the use of heparin may be harmful and alternative treatments may be needed. Consultation with hematology specialists is strongly recommended. The American Society of Hematology has published considerations relevant to the diagnosis and treatment of thrombosis with thrombocytopenia following administration of the Janssen COVID-19 Vaccine ( https://www.hematology.org/covid-19/vaccine-induced-immune-thrombotic-thrombocytopenia). Recipients of Janssen COVID-19 Vaccine should be instructed to seek immediate medical attention if they develop shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms (including severe or persistent headaches or blurred vision), or petechiae beyond the site of vaccination.
• Guillain-Barré Syndrome: Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination.
• Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Janssen COVID-19 Vaccine.
• Limitations of Vaccine Effectiveness: The Janssen COVID-19 Vaccine may not protect all vaccinated individuals.

ADVERSE REACTIONS

Adverse Reactions in Clinical Trials

Adverse reactions reported in a clinical trial following administration of the Janssen COVID-19 Vaccine include injection site pain, headache, fatigue, myalgia, nausea, fever, injection site erythema and injection site swelling. In clinical studies, severe allergic reactions, including anaphylaxis, have been reported following the administration of the Janssen COVID-19 Vaccine.

Adverse Reactions Identified during Post Authorization Use

Severe allergic reactions (including anaphylaxis), thrombosis with thrombocytopenia, Guillain-Barré syndrome, and capillary leak syndrome have been reported following administration of the Janssen COVID-19 Vaccine during mass vaccination outside of clinical trials.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Janssen COVID-19 Vaccine.

Reporting Adverse Events and Vaccine Administration Errors

The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for mandatory reporting of the listed events following Janssen COVID-19 Vaccine administration to the Vaccine Adverse Event Reporting System (VAERS):

• Vaccine administration errors whether or not associated with an adverse event,
  
• Serious adverse events (irrespective of attribution to vaccination),
  
• Cases of Multisystem Inflammatory Syndrome (MIS) in adults,
  
• Cases of COVID-19 that result in hospitalization or death.

Instructions for Reporting to VAERS

The vaccination provider enrolled in the federal COVID-19 Vaccination Program should complete and submit a VAERS form to FDA using one of the following methods below. Reports should include the words “Janssen COVID-19 Vaccine EUA” in the description section of the report as the first line.

• Complete and submit the report online: https://vaers.hhs.gov/reportevent.html, or
• If you are unable to submit this form electronically, you may fax it to VAERS at 1-877-721-0366. If you need additional help submitting a report you may call the VAERS toll free information line at 1-800-822-7967 or send an email to info@vaers.org.

Report adverse events to Janssen Biotech,, Inc. by calling 1-800-565-4008 or provide a copy of the VAERS form by faxing 1-215-293-9955.

PREGNANCY AND LACTATION

• Pregnancy: Available data on Janssen COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.
  
• Lactation: Data are not available to assess the effects of Janssen COVID-19 Vaccine on the breastfed infant or on milk production/excretion.

DOSING AND SCHEDULE

The Janssen COVID-19 Vaccine is administered intramuscularly as a single dose (0.5 mL).

There are no data available on the use of the Janssen COVID-19 Vaccine to complete a vaccination series initiated with another COVID-19 Vaccine.

Please read Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including full EUA Prescribing Information available at www.JanssenCOVID19Vaccine.com/EUA-factsheet.

As part of the Biden-Harris Administration’s ongoing commitment to increasing access to vaccinations and improving health equity, CMS is expanding opportunities for people to receive COVID-19 vaccinations in their home. To ensure Medicare beneficiaries who have difficulty leaving their homes or are otherwise hard-to-reach can receive the vaccination, health care providers can now receive additional payments for administering vaccines to multiple residents in one home setting or communal setting of a home. 

This announcement aims to further boost the administration of COVID-19 vaccination – including second and third doses – in smaller group homes, assisted living facilities, and other group living situations by allowing vaccine providers to receive the increased payment up to 5 times when fewer than 10 Medicare beneficiaries get the vaccine on the same day in the same home or communal setting. This policy will help ensure that at-risk patients in smaller settings have the same opportunities as others to receive the vaccination.

While many Medicare beneficiaries are able to receive a COVID-19 vaccine at a retail pharmacy or from a health care provider, some people have great difficulty leaving their homes or cannot easily access vaccination in these settings. These individuals are often at-risk patients who could require complex care if they contracted COVID-19 and needed to be hospitalized. To better serve this group, Medicare previously increased the total payment amount for at-home vaccination from approximately $40 to approximately $75 per vaccine dose, in certain circumstances.

Delivering COVID-19 vaccination to access-challenged and hard-to-reach individuals poses some unique challenges, such as ensuring appropriate vaccine storage temperatures, handling, and administration. Along with the CDC guidance, this announcement helps vaccine providers meet these challenges and successfully administer vaccinations.

The additional payment amount also accounts for the clinical time needed to monitor a beneficiary after the vaccine is administered, as well as the upfront costs associated with administering the vaccine safely and appropriately in a beneficiary’s home. The payment rate for administering each dose of a COVID-19 vaccine, as well as the additional in-home payment amount, is geographically adjusted based on where the service is furnished.

Click here to view a helpful infographic.

How to Find a COVID-19 Vaccine:

As states and the federal government continue to break down barriers – like where vaccines can be administered – resources for connecting communities to vaccination options remain key. Unvaccinated individuals and those looking to assist friends and family can:

1. Visit vaccines.gov (English) or vacunas.gov (Spanish) to search for vaccines nearby
2. Text GETVAX (438829) for English or VACUNA (822862) for Spanish for near-instant access to details on three vaccine sites in the local area
3. Call the National COVID-19 Vaccination Assistance Hotline at 1-800-232-0233 (TTY: 1-888-720-7489) for assistance in English and Spanish

Coverage of COVID-19 Vaccines:

The federal government is providing the COVID-19 vaccine free of charge or with no cost-sharing for Medicare beneficiaries. As a condition of receiving free COVID-19 vaccines from the federal government, vaccine providers cannot charge patients any amount for administering the vaccine.

Because no patient can be billed for COVID-19 vaccinations, CMS and its partners have provided a variety of information online for providers vaccinating all Americans regardless of their insurance status:

• Original Medicare and Medicare Advantage: Beneficiaries with Medicare pay nothing for COVID-19 vaccines or their administration, and there is no applicable copayment, coinsurance or deductible.
  
• Medicaid and the Children’s Health Insurance Program (CHIP):State Medicaid and CHIP agencies must cover COVID-19 vaccine administration with no cost sharing for nearly all beneficiaries during the COVID-19 Public Health Emergency (PHE) and (generally) for over a year after it ends. For the very limited number of Medicaid beneficiaries who are not eligible for this coverage (and do not receive it through other coverage they might have), providers may submit claims for reimbursement for administering the COVID-19 vaccine to underinsured individuals through the COVID-19 Coverage Assistance Fund, administered by the Health Resources and Services Administration (HRSA), as discussed below. Under the American Rescue Plan Act of 2021 (ARP), signed by President Biden on March 11, 2021, the federal matching percentage for state Medicaid and CHIP expenditures on COVID-19 vaccine administration is currently 100% (as of April 1, 2021), and will remain 100% for more than a year after the COVID-19 PHE ends. The ARP also expands coverage of COVID-19 vaccine administration under Medicaid and CHIP to additional eligibility groups. CMS recently updated the Medicaid vaccine toolkit to reflect the enactment of the ARP.
• Private Plans: The vaccine is free for people enrolled in most private health plans. The COVID-19 vaccines and the administration are covered without cost sharing for most enrollees, and such coverage must be provided both in-network and out-of-network during the PHE. Current regulations provide that out-of-network rates must be reasonable as compared to prevailing market rates, and the rules reference using the Medicare payment rates as a potential guideline for insurance companies. In light of CMS’s action, CMS expects health insurance issuers and group health plans to continue to ensure their rates are reasonable when compared to prevailing market rates. Under the conditions of participation in the CDC COVID-19 Vaccination Program, providers cannot charge plan enrollees any administration fee or cost sharing, regardless of whether the COVID-19 vaccine is administered in-network or out-of-network.

For individuals who are underinsured, vaccine providers may submit claims for reimbursement for administering the COVID-19 vaccine through the COVID-19 Coverage Assistance Fund administered by HRSA after the claim to the individual’s health plan for payment has been denied or only partially paid.

For individuals who are uninsured, vaccine providers may submit claims for reimbursement for administering the COVID-19 vaccine to individuals without insurance through the Provider Relief Fund, administered by HRSA. See information on the COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured Program.

More information on Medicare payment for COVID-19 vaccine administration – including a list of billing codes, payment allowances and effective dates – is available on the Medicare COVID-19 Vaccine Shot Payment webpage.

More information regarding the CDC COVID-19 Vaccination Program Provider Requirements and how the COVID-19 vaccine is provided through that program at no cost to recipients is available on the CDC COVID-19 Vaccination Program Provider Requirements and Support webpage.

• The AHCCCS fee-for-service rate for COVID-19 vaccine administration is $40 to administer single-dose vaccines.
• For a COVID-19 vaccine requiring a series of two doses, the initial dose administration payment rate is $40 and the second dose administration payment rate is $40.

Most Arizona counties are experiencing high or substantial transmission; Yuma and Cochise are the only counties in the state with moderate transmission.

Director of the Arizona Department of Health Services (ADHS), Dr. Cara Christ, advised that "'Everyone, whether [they're] fully vaccinated or not fully vaccinated, should wear a mask whenever [they] are indoors or around others that [they] do not live with.'"

Read more. 

• House calls: Healthcare professionals phone banking opportunity
  • When:
    • Wednesday, June 23 6-8pm ET
    • Saturday, June 26 2-4pm ET
    • Sunday, June 27 2-4pm ET
  • Link to sign up: https://www.mobilize.us/madetosave/event/395601/
  • Join us for Month of Action "House Call" Phone Banks! All healthcare and public health professionals and students are invited to join us to call people in key communities to listen to their concerns, answer any questions, and help them get their shot. All you need is a computer and your phone.

• Ask Me Anything about COVID-19: Healthcare providers participate in one-on-one conversations in your community about vaccination
  • When: Saturday, June 27 and Sunday, June 28
  • Information: The weekend of June 26-27, set up shop to answer vaccine questions wherever people are: a grocery store, barbershop, or community center. Partner with your local health department, church, or other organization located in underserved communities. We’ll share additional resources closer to that weekend. In the meantime, sign up through our partner commitment form, register your event(s) on Mobilize, and make a note to report back what happened so we can all learn!

As part of President Biden’s commitment to increasing access to vaccinations, CMS announced an additional payment amount for administering in-home COVID-19 vaccinations to Medicare beneficiaries who have difficulty leaving their homes or are otherwise hard-to-reach. This announcement further demonstrates continued efforts of the Biden-Harris Administration to meet people where they are and make it as easy as possible for all Americans to get vaccinated. There are approximately 1.6 million adults 65 or older who may have trouble accessing COVID-19 vaccinations because they have difficulty leaving home.

While many Medicare beneficiaries can receive a COVID-19 vaccine at a retail pharmacy, their physician’s office, or a mass vaccination site, some beneficiaries have great difficulty leaving their homes or face a taxing effort getting around their communities easily to access vaccination in these settings. To better serve this group, Medicare is incentivizing providers and will pay an additional $35 per dose for COVID-19 vaccine administration in a beneficiary’s home, increasing the total payment amount for at-home vaccination from approximately $40 to approximately $75 per vaccine dose. For a two-dose vaccine, this results in a total payment of approximately $150 for the administration of both doses, or approximately $70 more than the current rate.

“CMS is committed to meeting the unique needs of Medicare consumers and their communities – particularly those who are home bound or who have trouble getting to a vaccination site. That’s why we’re acting today to expand the availability of the COVID-19 vaccine to people with Medicare at home,” said CMS Administrator Chiquita Brooks-Lasure. “We’re committed to taking action wherever barriers exist and bringing the fight against the COVID-19 pandemic to the door of older adults and other individuals covered by Medicare who still need protection.”

Delivering COVID-19 vaccination to access-challenged and hard-to-reach individuals poses some unique challenges, such as ensuring appropriate vaccine storage temperatures, handling, and administration. The CDC has outlined guidance to assist vaccinators in overcoming these challenges. This announcement now helps to address the financial burden associated with accommodating these complications.

The additional payment amount also accounts for the clinical time needed to monitor a beneficiary after the vaccine is administered, as well as the upfront costs associated with administering the vaccine safely and appropriately in a beneficiary’s home. The payment rate for administering each dose of a COVID-19 vaccine, as well as the additional in-home payment amount, will be geographically adjusted based on where the service is furnished.

How to Find a COVID-19 Vaccine:

As this action demonstrates, a person’s ability to leave their home should not be an obstacle to getting the COVID-19 vaccine. As states and the federal government continue to break down barriers – like where vaccines can be administered – resources for connecting communities to vaccination options remain key. Unvaccinated individuals and those looking to assist friends and family can:

1. Visit vaccines.gov (English) or vacunas.gov (Spanish) to search for vaccines nearby
2. Text GETVAX (438829) for English or VACUNA (822862) for Spanish for near-instant access to details on three vaccine sites in the local area
3. Call the National COVID-19 Vaccination Assistance Hotline at 1-800-232-0233 (TTY: 1-888-720-7489) for assistance in English and Spanish

Coverage of COVID-19 Vaccines:

The federal government is providing the COVID-19 vaccine free of charge or with no cost-sharing for all people living in the United States. As a condition of receiving free COVID-19 vaccines from the federal government, vaccine providers cannot charge patients any amount for administering the vaccine.

Because no patient can be billed for COVID-19 vaccinations, CMS and its partners have provided a variety of information online for providers vaccinating all Americans regardless of their insurance status:

• Original Medicare and Medicare Advantage:Beneficiaries with Medicare pay nothing for COVID-19 vaccines or their administration, and there is no applicable copayment, coinsurance or deductible.
• Medicaid and the Children’s Health Insurance Program (CHIP):State Medicaid and CHIP agencies must cover COVID-19 vaccine administration with no cost sharing for nearly all beneficiaries during the COVID-19 Public Health Emergency (PHE) and for over a year after it ends. For the very limited number of Medicaid beneficiaries who are not eligible for this coverage (and do not receive it through other coverage they might have), providers may submit claims for reimbursement for administering the COVID-19 vaccine to underinsured individuals through the COVID-19 Coverage Assistance Fund, administered by the Health Resources and Services Administration (HRSA), as discussed below. Under the American Rescue Plan Act of 2021 (ARP), signed by President Biden on March 11, 2021, the federal matching percentage for state Medicaid and CHIP expenditures on COVID-19 vaccine administration is currently 100% (as of April 1, 2021), and will remain 100% for more than a year after the COVID-19 PHE ends. The ARP also expands coverage of COVID-19 vaccine administration under Medicaid and CHIP to additional eligibility groups. CMS recently updated the Medicaid vaccine toolkit to reflect the enactment of the ARP at https://www.medicaid.gov/state-resource-center/downloads/covid-19-vaccine-toolkit.pdf.
• Private Plans: The vaccine is free for people enrolled in private health plans and issuers COVID-19 vaccine and its administration is covered without cost sharing for most enrollees, and such coverage must be provided both in-network and out-of-network during the PHE. Current regulations provide that out-of-network rates must be reasonable as compared to prevailing market rates, and the rules reference using the Medicare payment rates as a potential guideline for insurance companies. In light of CMS’s increased Medicare payment rates, CMS will expect health insurance issuers and group health plans to continue to ensure their rates are reasonable when compared to prevailing market rates. Under the conditions of participation in the CDC COVID-19 Vaccination Program, providers cannot charge plan enrollees any administration fee or cost sharing, regardless of whether the COVID-19 vaccine is administered in-network or out-of-network.

The Biden-Harris Administration is providing free access to COVID-19 vaccines for every adult living in the United States. For individuals who are underinsured, providers may submit claims for reimbursement for administering the COVID-19 vaccine through the COVID-19 Coverage Assistance Fund administered by HRSA after the claim to the individual’s health plan for payment has been denied or only partially paid. Information is available at https://www.hrsa.gov/covid19-coverage-assistance.

For individuals who are uninsured, providers may submit claims for reimbursement for administering the COVID-19 vaccine to individuals without insurance through the Provider Relief Fund, administered by HRSA. Information on the COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured Program is available at https://www.hrsa.gov/CovidUninsuredClaim.

More information on Medicare payment for COVID-19 vaccine administration – including a list of billing codes, payment allowances and effective dates – is available at https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment.

More information regarding the CDC COVID-19 Vaccination Program Provider Requirements and how the COVID-19 vaccine is provided through that program at no cost to recipients is available at https://www.cdc.gov/vaccines/covid-19/vaccination-provider-support.html.

The Arizona Department of Health Services (ADHS) recently released the following bulletin regarding wasted/expired doses. It is understood that between demand decreasing, more providers offering vaccines, vials increasing in size, and more people being vaccinated that doses may get wasted or end up expiring. We should still take every effort to avoid either of those things. This bulletin has some best practices and the accompanying attachment outlines how to account for expired/wasted doses. We will still need to work together, strategize, and ensure we are getting every dose into an arm to the fullest extent possible:

You have excess COVID-19 vaccine inventory (i.e. inventory that will expire prior to use). What should you do?

• Keep the vaccine stored at the proper temperatures.
• Determine the updated expiration date based on the cold storage unit type.
  • Example: Once Moderna/Pfizer doses are placed in the refrigerator they must be used within 30 days, regardless of the original expiration date published online. Once doses have been refrigerated, they cannot be re-frozen.
• The expiration dates may be extended as vaccines are studied. Check the lot number on the manufacturer site for current/updated expiration dates.
  • Moderna expiration date site
  • Pfizer expiration date is on tray/vial
  • Janssen expiration date site

Best Practice — find patients to give the doses to:

• Pull a reminder recall report in ASIIS to see who needs 2nd doses (for Pfizer and Moderna).
• Vaccinate family members or friends who accompany patients to medical visits even if they are not established patients at the vaccinating practice.
• Conduct outreach to employers or other community partners that have a large membership or network to arrange vaccination events.
• Contact additional persons (i.e., from a waitlist or through personal contacts of persons being vaccinated) to use as many vaccine doses as possible.
• Contact long term care facilities to see if they have new staff or new residents that need vaccinated
• Offer virtual “office hours” for patients who want to ask questions. This could be someone on call at a specific time or setting up a time to interact with patients and families via web conference call or on a livestream to share key messages about vaccination.
• Make vaccination the social norm. Highlight how many people are getting vaccinated where applicable to encourage vaccination (e.g., “87% of my patients over 50 have gotten their COVID-19 vaccine. Get yours today!”).
• Ask about vaccination status for patients that are being seen for other reasons and potentially vaccinate them.

Second Best — transfer the doses to a provider that can use them prior to expiration:

• Find an active COVID-19 onboarded vaccinator that can use the doses before expiration and complete the transfer process in ASIIS.
• Both the sending and receiving providers will email data logger reports to ArizonaVFC@azdhs.gov.
• Transfers must be approved in ASIIS prior to moving the doses.
• Enter the transfer in ASIIS prior to moving the doses.
  • Information you will need for ASIIS
    • The organization and facility sending the doses
    • The organization and facility receiving the doses
    • The quantity
    • The lot number
• Check the status of the requested transfer in ASIIS.
• When the doses arrive, mark them “received” in ASIIS. Do not administer doses before “receiving” them in the ASIIS inventory.
• Only onboarded, active COVID-19 vaccine providers may receive COVID-19 vaccines.
• Follow the USP transfer guidelines when packing the doses for transfer.
  • Once frozen doses have been thawed they cannot go back into a freezer.
• Wherever the vaccines are, data loggers must be with them to monitor the temperatures.
• The ancillary kit and diluent must also be transferred with the doses.
• Sending provider must communicate with the receiving provider the number of days the product has been stored in each cold storage unit type and the updated expiration date.
  • Example:
    • Provider ABC placed Moderna doses in the refrigerator on 5/1/2021. Provider ABC will not be able to use the doses within 30 days. Provider ABC transfers the doses to provider XYZ on 5/20/21. Provider XYZ must use the refrigerated Moderna doses before 6/1/2021.
• Once doses have been refrigerated, they cannot be re-frozen.

If vaccine goes unused:

• If the vaccine expires before you can use it, complete the wastage form, email it to arizonavfc@azdhs.gov and dispose of the vaccine.
  • Click here to view an outline of how to account for expired or wasted doses.
• Expired/wasted COVID-19 doses should be disposed of in a sharps container or per the hazardous waste policy in your office. Expired/wasted COVID-19 vaccines do NOT go back to McKesson or Pfizer at this time.

• The goal is to increase vaccine confidence and for everyone who wants to be vaccinated to have every opportunity to be fully vaccinated once they become eligible.
• CDC and their partners are doing everything possible to minimize the amount of vaccine that goes unused.
• Vaccine wastage may increase as the vaccine rollout continues because:
  • more providers, including smaller provider sites, are now receiving vaccine,
  • vial sizes for some vaccines have increased,
  • vaccine vials may be opened without every dose being used
• To ensure providers do not miss an opportunity to vaccinate every eligible person, CDC recommends:
  • Providers follow clinical best practice for vaccination as well as best practices when managing inventory to maximize vaccination and minimize dose wastage.
• Providers should not miss any opportunities to vaccinate every eligible person who presents at a vaccination site, even if it means puncturing a multidose vial to administer vaccine without having enough people available to receive each dose.
  • Consider establishing and promoting standing vaccination days or half-days to increase likelihood of larger numbers of people presenting for vaccination on the same day.
  • Vaccinate family members or friends who accompany patients to medical visits even if they are not established patients at the vaccinating practice.
  • Continue outreach to employers or other community partners that have a large membership or network to arrange vaccination events.
  • As a contingency plan, vaccine providers should attempt to contact additional persons (i.e., from a waitlist or through personal contacts of persons being vaccinated) to use as many vaccine doses as possible.
  • Once punctured, multidose vials must be used within:
  • The more Americans who get vaccinated the fewer COVID-19 cases, hospitalizations, outbreaks, and deaths that will occur.

While we want to continue to follow best practices to use every dose possible, we do not want that to be at the expense of missing an opportunity to vaccinate every eligible person when they are ready to get vaccinated.

As part of the ongoing response to address the COVID-19 pandemic, CMS has increased the Medicare payment rate for administering monoclonal antibodies to treat beneficiaries with COVID-19, continuing coverage under the Medicare Part B COVID-19 vaccine benefit. Beneficiaries pay nothing out of pocket, regardless of where the service is furnished – including in a physician’s office, health care facility, or at home.

Effective May 6, the national average payment rate will increase from $310 to $450 for most health care settings. In support of providers’ efforts to prevent the spread of COVID-19, CMS will also establish a higher national payment rate of $750 when monoclonal antibodies are administered in the beneficiary’s home, including the beneficiary’s permanent residence or temporary lodging (e.g., hotel/motel, cruise ship, hostel, or homeless shelter).

The new national payment rate for at-home administration of monoclonal antibodies accounts for increased costs associated with the one-on-one nature of this care model. These higher national average payment rates reflect additional information provided to CMS about the costs of providing these services in a safe and timely manner, such as clinical staff and personal protective equipment. This action also means Medicare payments to providers and suppliers will be more aligned to their costs to administer these products.

CMS’s goal during the COVID-19 public health emergency has been to ensure that the agency is supporting beneficiary access to care. This new policy is based on timely, valuable input from stakeholders including the home health and ambulatory infusion industries on the costs associated with administering monoclonal antibodies.

CMS is updating the set of toolkits for providers, states, and insurers to help the health care system swiftly administer monoclonal antibody treatment with these new Medicare payment rates on the Monoclonal Antibody COVID-19 Infusion webpage.

In addition, CMS is updating coding resources for providers on the COVID-19 Vaccines and Monoclonal Antibodies webpage.

For additional clinical information about COVID-19 monoclonal antibodies, please visit:

• NIH Anti-SARS-CoV-2 Monoclonal Antibodies webpage
• NIH Therapeutic Management of Adults With COVID-19 webpage
• HHS COVID-19 Resources for Health Care Professionals webpage

COMPLETING THE ONBOARDING PROCESS

To be eligible to order COVID-19 vaccine doses, physicians must complete the onboarding process. Click here to complete the onboarding form and find answers to frequently asked questions. The onboarding process includes providing ADHS with the following information:

• Contact and shipping details 
  • Facility location information
  • Signatory provider info (title, license, NPI)
  • Primary and backup vaccine coordinator information
  • Not sure if you’re a VFC/VCA provider? Select no when it asks if you are a VFC provider; this is not necessary to participate
• Storage and handling
  • Photos of your cold storage units showing the inside of the units
  • Brand and model of each cold storage unit
  • Data logger usage info
  • Read requirements
• Arizona State Immunization Information System (ASIIS)
  • Are you currently entering/transferring immunization data into ASIIS?
  • Read requirements
• Vaccine planning
  • Read through content so you can plan and be prepared
• CDC Agreement Section A
  • CMO & CEO signatures
  • For organizations: follow the instructions for Section A in FAQs. Follow the decision tree on the final page to determine whether you need to follow organization instructions.
• CDC Agreement Section B
  • Facility type
  • Populations served
  • Storage unit capacity
  • Must be signed by the signatory provider/the primary vaccine coordinator
• Prescribing Providers (part of CDC Agreement)
  • Submit multiple times - one for each prescribing provider
  • Enter each prescriber’s name, title, and license number

AFTER COMPLETING THE ONBOARDING PROCESS

Once you have completed the onboarding process, you may login to ASIIS to order vaccine doses. Please note that physician offices are only eligible to order 200 vaccine doses at a time. Click here to find a guide on how to order doses on ASIIS.

HAVE MORE QUESTIONS?

If you have questions about the process of ordering COVID-19 vaccine doses as a physician, check out these slides from the ADHS' weekly brown bag meeting for pandemic providers. 

• Log into ASIIS
• Go to Orders/Transfers> Create/View Orders
• Check the Status of your order. It will change to one of the following:
  • In Manual Review > Pending State Approval > Approved > Shipped
  • In Manual Review > Pending State Approval > Denied

***Note: If an order is denied by AIPO the Primary and Back-Up Coordinator will be notified.

Once an order is shipped, tracking information is available within the order.

• Go to Orders/Transfers> Create/View Orders> Select arrow for Inbound Order
• Click on Cancel when done

Do Not Use Antibody Testing to Assess Immunity to SARS-CoV-2 After COVID-19 Vaccination
Guidance for Healthcare Providers

Some providers have ordered serologic testing for SARS-CoV-2 and then look for ways to get their patients an additional dose of vaccine when the antibody level is “low” or “negative.”

The current COVID-19 vaccines have been approved under FDA Emergency Use Authorization with Pfizer and Moderna for use as a two-dose vaccine series and Janssen as a one-dose vaccine.

The CDC does not currently recommend testing for immunity to SARS-CoV-2 following COVID-19 vaccination:

• The clinical utility of post-vaccination testing has not been established.
• Antibody tests currently authorized under an EUA have variable sensitivity, specificity, as well as positive and negative predictive values, and are not authorized for the assessment of immune response in vaccinated people.
• The serologic correlates of protection have not been established.
• Antibody testing does not evaluate the cellular immune response, which may also play a role in vaccine-mediated protection.

See the CDC’s “Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States” for more information. This particular guidance is found under the Laboratory Testing section.

CDC recommendations on serologic testing after vaccination, when to re-vaccinate, or when to give additional doses of COVID-19 vaccines may be updated when additional information is available.

The Janssen COVID-19 Vaccine was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA).

• The Janssen COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized by FDA through an Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019 (COVID-19) in individuals 18 years of age and older.
• The emergency use of this product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the medical product under Section 564(b)(1) of the FD&C Act, unless the declaration is terminated or authorization revoked sooner.

You may have received an email regarding the topic mentioned below prior to EUA being granted and I would like to update you with regard to the same.

The Janssen COVID-19 Vaccine expiration date may be updated as the product is undergoing stability assessment studies. Because no expiration date appears on the carton or vial, please query the expiration date either online or by phone.

Attached is an updated expiry information resource that serves to replace the previously distributed Vaxcheck flashcard prior to EUA being granted. You can also view a video detailing the process of checking the Janssen COVID-19 Vaccine expiry information by clicking here.

To register for an educational webinar on the Janssen COVID-19 Vaccine, including more information about Vaxcheck.jnj, please click here. If you have any product-related questions, please call 1-800-JANSSEN (526-7736). Resources are also available here. 

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Do not administer the Janssen COVID-19 Vaccine to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Janssen COVID-19 Vaccine.

WARNINGS AND PRECAUTIONS

• Management of Acute Allergic Reactions: Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Janssen COVID-19 Vaccine. Monitor Janssen COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines.
• Thrombosis with Thrombocytopenia: Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of thrombosis involving the cerebral venous sinuses and other sites (including but not limited to the large blood vessels of the abdomen and the veins of the lower extremities) combined with thrombocytopenia and with onset of symptoms approximately one to two weeks after vaccination. Most cases of thrombosis with thrombocytopenia reported following the Janssen COVID-19 Vaccine have occurred in females ages 18 through 49 years; some have been fatal. Specific risk factors for thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine and the level of potential excess risk due to vaccination are under investigation. Based on currently available evidence, a causal relationship between thrombosis with thrombocytopenia and the Janssen COVID-19 Vaccine is plausible.

Healthcare professionals should be alert to the signs and symptoms of thrombosis with thrombocytopenia in individuals who receive the Janssen COVID-19 Vaccine. The clinical course shares features with autoimmune heparin-induced thrombocytopenia. In individuals with suspected thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine, the use of heparin may be harmful and alternative treatments may be needed. Consultation with hematology specialists is strongly recommended. The American Society of Hematology has published considerations relevant to the diagnosis and treatment of thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine.

Recipients of the Janssen COVID-19 Vaccine should be instructed to seek immediate medical attention if they develop shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms (including severe or persistent headaches or blurred vision), or petechiae beyond the site of vaccination.

• Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Janssen COVID-19 Vaccine.
• Limitations of Vaccine Effectiveness: The Janssen COVID-19 Vaccine may not protect all vaccinated individuals.

ADVERSE REACTIONS

Adverse reactions reported in a clinical trial following administration of the Janssen COVID-19 Vaccine include injection site pain, headache, fatigue, myalgia, nausea, fever, injection site erythema and injection site swelling. In clinical studies, severe allergic reactions, including anaphylaxis, have been reported following the administration of the Janssen COVID-19 Vaccine.

Thrombosis involving large blood vessels, including the cerebral venous sinuses, portal vein, lower extremity veins, and pulmonary artery, with thrombocytopenia have been reported following the Janssen COVID-19 Vaccine.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Janssen COVID-19 Vaccine.

Reporting Adverse Events and Vaccine Administration Error

The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for mandatory reporting of the listed events following Janssen COVID-19 Vaccine administration to the Vaccine Adverse Event Reporting System (VAERS):

• Vaccine administration errors whether or not associated with an adverse event,
• Serious adverse events (irrespective of attribution to vaccination),
• Cases of Multisystem Inflammatory Syndrome (MIS) in adults,
• Cases of COVID-19 that result in hospitalization or death.

Instructions for Reporting to VAERS

The vaccination provider enrolled in the federal COVID-19 Vaccination Program should complete and submit a VAERS form to FDA using one of the following methods below. Reports should include the words “Janssen COVID-19 Vaccine EUA” in the description section of the report as the first line.

• Complete and submit the report online: https://vaers.hhs.gov/reportevent.html, or
• If you are unable to submit this form electronically, you may fax it to VAERS at 1-877-721-0366. If you need additional help submitting a report you may call the VAERS toll free information line at 1-800-822-7967 or send an email to info@vaers.org.

Report adverse events to Janssen Biotech, Inc. by calling 1-800-565-4008 or provide a copy of the VAERS form by faxing 1-215-293-9955.

PREGNANCY AND LACTATION

• Pregnancy: Available data on Janssen COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.
• Lactation: Data are not available to assess the effects of Janssen COVID-19 Vaccine on the breastfed infant or on milk production/excretion.

DOSING AND SCHEDULE

The Janssen COVID-19 Vaccine is administered intramuscularly as a single dose (0.5 mL).

There are no data available on the use of the Janssen COVID-19 Vaccine to complete a vaccination series initiated with another COVID-19 vaccine.

Please read Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including full EUA Prescribing Information available here.

On April 16, the Food and Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) for bamlanivimab, when administered alone, due to a sustained increase in COVID-19 viral variants in the U.S. that are resistant to this antibody therapy. The FDA determined that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks.

Medicare will cover and pay for bamlanivimab, when administered alone, for dates of service from November 10, 2020 – April 16, 2021.

The FDA indicates that alternative monoclonal antibody therapies remain appropriate to treat COVID-19 patients, and health care providers may continue using these authorized therapies when administered together:

• Casirivimab & imdevimab
• Bamlanivimab & etesevimab

For more information on monoclonal antibody treatment in Arizona, click here. 

Resources:

• Fact Sheet for Health Care Providers EUA of Casirivimab and Imdevimab Section 15, Antiviral Resistance
• Fact Sheet for Health Care Providers EUA of Bamlanivimab and Etesevimab Section 15, Antiviral Resistance
• Monoclonal Antibody COVID-19 Infusion webpage