| COVID-19 Therapeutics Options by Exposure and Infection Status | | 175 | | COVID-19 Therapeutics Options by Exposure and Infection Status | <p><strong>āSARS-CoV-2 Negative (-)</strong></p><table cellspacing="0" width="100%" class="ms-rteTable-7" style="border-spacing:0px;overflow-x:auto;"><tbody style="box-sizing:border-box;"><tr class="ms-rteTableHeaderRow-7" style="box-sizing:border-box;"><th class="ms-rteTableHeaderEvenCol-7" rowspan="1" colspan="1" style="box-sizing:border-box;width:298.5px;"><p><strong>Not Exposed</strong></p></th><th class="ms-rteTableHeaderOddCol-7" rowspan="1" colspan="1" style="box-sizing:border-box;width:298.5px;"><p><strong>Exposed</strong></p></th></tr><tr class="ms-rteTableOddRow-7" style="box-sizing:border-box;"><td class="ms-rteTableEvenCol-7" style="box-sizing:border-box;"><p>Pre-Exposure Prophylaxis (PrEP)</p></td><td class="ms-rteTableOddCol-7" style="box-sizing:border-box;"><p>Post-Exposure Prophylaxis (PEP)</p></td></tr><tr class="ms-rteTableEvenRow-7" style="box-sizing:border-box;"><td class="ms-rteTableEvenCol-7" style="box-sizing:border-box;height:66px;"><p></p><p></p><p>Currently no āauthorizeād treatmentsā<br></p><p></p><br></td><td class="ms-rteTableOddCol-7" style="box-sizing:border-box;height:66px;"><p>Currently no authorized treatmeānts<br></p></td></tr></tbody></table><p><br></p><p><strong>SARS-CoV-2 Positive (+)</strong></p><table cellspacing="0" width="100%" class="ms-rteTable-9" style="border-spacing:0px;overflow-x:auto;"><tbody style="box-sizing:border-box;"><tr class="ms-rteTableHeaderRow-9" style="box-sizing:border-box;"><th class="ms-rteTableHeaderEvenCol-9" rowspan="1" colspan="1" style="box-sizing:border-box;width:597px;"><p><strong>Mild to Moderate Illness in Individual at High Risk for Disease Progression</strong></p></th></tr><tr class="ms-rteTableOddRow-9" style="box-sizing:border-box;"><td class="ms-rteTableEvenCol-9" style="box-sizing:border-box;"><p>Treatment options, in order of preference:</p><p>1. Nirmatrelvir/ritonavir (Paxlovid)</p><p>2. Remdesivir (Veklury)<br></p><p>If above options are unavailable or not medically appropriate, can consider (in alphabetical order):<br></p><p>3. Molnupiravir (Lagevrio)</p><div><br><br></div></td></tr></tbody></table><br><div>āU.S. Department of Health and Human Services (HHS) summary table:Ā <a href="https://aspr.hhs.gov/COVID-19/Therapeutics/Documents/side-by-side-overview.pdf" target="_blank">Side-by-Side Overview of Therapies</a>Ā (PDF).</div><div><br></div><div>FDA approved/authorized COVID-19 drug:Ā <a href="https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs" target="_blank">Coronavirus (COVID-19) | Drugs | FDA</a><br></div> | | | |
| Clinical Decision Making Guides | | 181 | | Clinical Decision Making Guides | <p>āāEffective treatment for outpatients with mild-to-moderate COVID-19 is available and should be offered to all eligibleĀ patients. <strong>Providers should have a low threshold to prescribe COVID-19 therapeutics given the broad range of individuals who are at higher risk for severe COVID-19 and can benefit from COVID-19 treatment.</strong>Ā <br></p><p>Multiple factors must be considered when selecting the appropriate treatment for outpatient with COVID-19, includingĀ patient-specific factors such as clinical/medical conditions and potential drug-drug interactionsĀ and healthcare system factors such as drug availability and feasibility of drug administration.Ā Providers should review product EUAs as well as the NIH Treatment Guidelines linked below.<br><br></p><p><strong>Treatment Guidelines</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://www.covid19treatmentguidelines.nih.gov/" target="_blank">COVID-19 Treatment Guidelines (nih.gov)</a></p></li><li><p><a href="https://www.covid19treatmentguidelines.nih.gov/management/">Clinical ManagementĀ | COVID-19 āTreatment Guidelines (nih.gov)ā</a><br></p></li><li style="box-sizing:border-box;"><p><a href="https://aspr.hhs.gov/COVID-19/Therapeutics/Pages/default.aspx" target="_blank">HHS Clinical Implementation Guide</a>Ā (PDF)<br></p></li><li style="box-sizing:border-box;"><p><a href="https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/">Infection Disease Society of America (IDSA) Treatment Guidelines</a><br></p></li></ul><p>T<strong>reatment Algorithms (Flow Charts)</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li style="box-sizing:border-box;"><p><a href="https://aspr.hhs.gov/COVID-19/Therapeutics/Documents/COVID-Therapeutics-Decision-Aid.pdf" target="_blank">HHS Outpatient Therapeutics Decision Aid</a>Ā (PDF)</p></li><li style="box-sizing:border-box;"><p><a href="https://www.idsociety.org/globalassets/covid-19-real-time-learning-network/outpatientroadmap-v10.pdf" target="_blank">IDSA Outpatient Treatment Roadmap</a>Ā (PDF)</p></li></ul><p><strong>Drug Interaction Checker</strong></p><ul><li><p><a href="https://covid19-druginteractions.org/view_all_interactions" target="_blank">Liverpool COVID-19 Interactions (covid19-druginteractions.org)</a><br></p></li><li><p><a href="https://www.covid19treatmentguidelines.nih.gov/therapies/antivirals-including-antibody-products/ritonavir-boosted-nirmatrelvir--paxlovid-/paxlovid-drug-drug-interactions/">NIH Paxlovid Interaction Guide (nih.gov)ā</a><br></p></li></ul><p><strong>COVID-19 Variant Information</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://covid.cdc.gov/covid-data-tracker/#variant-proportions" target="_blank">CDC Variant Tracker</a></p></li><li><p><a href="https://covid.cdc.gov/covid-data-tracker/#circulatingVariants" target="_blank">CDC Nowcast Estimates</a></p></li></ul><p><strong>Underlying Medical Conditions</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html" target="_blank">Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19: Information for Healthcare Professionals | CDC</a></p></li><li style="box-sizing:border-box;"><p><a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html" target="_blank">COVID-19 Vaccines for Moderately or Severely Immunocompromised People | CDC</a><br></p></li></ul> | | | |
| Viral Rebound | | 305 | | Viral Rebound | <p><br></p><div>Recurrence of symptoms, or ārebound,ā of COVID-19 has been noted in a small but significant percentage of cases. Media reports labelled COVID-19 symptom recurrence after treatment with the oral antiviral agent, Paxlovid (nirmatrelvir/ritonavir), as āPaxlovid rebound,ā creating misperceptions in both healthcare providers and the public that Paxlovid is the root cause of COVID-19 rebound. COVID-19 viral rebound may occur in both untreated and treated people.<br></div><div><br></div><div>Although COVID-19 rebound may occur after treatment with antivirals, there is currently no evidence that this rebound is the result of SARS-CoV-2 resistance to therapeutics. Based on case reports, recurrent symptoms after treatment with antivirals appear to be mild. Because the goal of antiviral treatment is avoiding progression to severe disease, recurrent mild to moderate symptoms do not indicate treatment failure. Individuals with COVID-19 symptom recurrence shouldĀ follow CDPHĀ and <a href="https://www.cdc.gov/coronavirus/2019-ncov/your-health/isolation.html">CDCĀ guidance regarding isolationā</a> of infected patients regardless of their treatment status. Paxlovid continues to be recommended for the treatment of mild to moderate COVID-19 among persons at high risk for progression to severe disease.<br></div><div><br></div> | | | |
| Antivirals Overview | | 177 | | Antivirals Overview | <table cellspacing="0" width="100%" class="ms-rteTable-4" style="border-spacing:0px;overflow-x:auto;"><tbody style="box-sizing:border-box;"><tr class="ms-rteTableHeaderRow-4" style="box-sizing:border-box;"><th class="ms-rteTableHeaderEvenCol-4" rowspan="1" colspan="1" style="box-sizing:border-box;width:145.672px;"><p><strong>āāāDrug</strong></p></th><th class="ms-rteTableHeaderOddCol-4" rowspan="1" colspan="1" style="box-sizing:border-box;width:102.328px;"><p><strong>Route</strong></p></th><th class="ms-rteTableHeaderEvenCol-4" rowspan="1" colspan="1" style="box-sizing:border-box;width:105.75px;"><p><strong>Age groups authorized for treatment</strong></p></th><th class="ms-rteTableHeaderOddCol-4" rowspan="1" colspan="1" style="box-sizing:border-box;width:96.4688px;"><p><strong>Timing of Treatment</strong></p></th><th class="ms-rteTableHeaderEvenCol-4" rowspan="1" colspan="1" style="box-sizing:border-box;width:130.031px;"><p><strong>Effectiveness</strong></p></th><th class="ms-rteTableHeaderOddCol-4" rowspan="1" colspan="1" style="box-sizing:border-box;width:138.75px;"><p><strong>Activity Against Variants Currently Circulating</strong></p></th></tr><tr class="ms-rteTableOddRow-4" style="box-sizing:border-box;"><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p><strong>Nirmatrelvir with ritonavir (Paxlovid)</strong></p><p>Orally twice daily for 5 days</p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;"><li style="box-sizing:border-box;"><p>For patients with normal/mild renal impairment (eGFR > 60 mL/min): 300 mg nirmatrelvir with 100 mg ritonavir</p></li><li style="box-sizing:border-box;"><p>For patients with moderate renal impairment (eGFR ā„ 30 to < 60 mL/min): 150 mg nirmatrelvir with 100 mg ritonavir</p></li></ul></td><td class="ms-rteTableOddCol-4" style="box-sizing:border-box;"><p>Oral</p></td><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p>12 years and older and weighing at least 40 kg</p></td><td class="ms-rteTableOddCol-4" style="box-sizing:border-box;"><p>As soon as possible, but within 5 days of symptom onset</p></td><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p>Compared to placebo,Ā <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizers-novel-covid-19-oral-antiviral-treatment-candidate" target="_blank">a relative risk reduction of 89%</a>Ā in hospitalizations or deaths.</p></td><td class="ms-rteTableOddCol-4" style="box-sizing:border-box;"><p>Effective againstĀ Omicron, including BA.2 subvariant</p></td></tr><tr class="ms-rteTableEvenRow-4" style="box-sizing:border-box;"><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p><strong>Remdesivir (Veklury)</strong><br></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;"><li style="box-sizing:border-box;"><p>For adults and pediatric patients weighing ā„ 40 kg: 200 mgĀ IV on Day 1, followed by 100 mgĀ IV daily on Days 2 and 3</p></li><li style="box-sizing:border-box;"><p>For pediatric patients ā„ 28 days old and weighing ā„ 3 kg to < 40 kg: 5 mg/kg IV on Day 1, followed by 2.5 mg/kg IV daily on Days 2 and 3.</p></li></ul></td><td class="ms-rteTableOddCol-4" style="box-sizing:border-box;"><p>Intravenous</p></td><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p>FDA approved for mild to moderately ill adult and pediatric (28 days of age and older weighing at least 3 kilograms) outpatients who are at risk of disease progression.<br></p></td><td class="ms-rteTableOddCol-4" style="box-sizing:border-box;"><p>As soon as possible, but within 7 days of symptom onset</p></td><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p>Compared to placebo,Ā <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2116846" target="_blank">a relative risk reduction of 87%</a>Ā in hospitalizations or deaths.</p></td><td class="ms-rteTableOddCol-4" style="box-sizing:border-box;"><p>Effective againstĀ Omicron, including BA.2 subvariant</p></td></tr><tr class="ms-rteTableOddRow-4" style="box-sizing:border-box;"><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p><strong>Molnupiravir (Lagevrio) 800 mg</strong></p><p>Orally twice daily for 5 days</p></td><td class="ms-rteTableOddCol-4" style="box-sizing:border-box;"><p>Oral</p></td><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p>18 years and older</p></td><td class="ms-rteTableOddCol-4" style="box-sizing:border-box;"><p>As soon as possible, but within 5 days of symptom onset</p></td><td class="ms-rteTableEvenCol-4" style="box-sizing:border-box;"><p>Compared to placebo,Ā <a href="https://www.merck.com/news/merck-and-ridgeback-biotherapeutics-provide-update-on-results-from-move-out-study-of-molnupiravir-an-investigational-oral-antiviral-medicine-in-at-risk-adults-with-mild-to-moderate-covid-19/" target="_blank">a relative risk reduction of 30%</a>Ā in hospitalizations or deaths.</p></td><td class="ms-rteTableOddCol-4" style="box-sizing:border-box;"><p>Effective againstĀ Omicron, including BA.2 subvariant<br><br><br></p></td></tr></tbody></table><p><br></p><p><br></p> | | | |
| Guidance on Antivirals | | 180 | | Guidance on Antivirals | <p>āāāāAntivirals prevent viral replication through multiple processes. There are currently two oral antivirals, nirmatrelvir/ritonavir (Paxlovid) and molnupiravir (Lagevrio), that are authorized for outpatient treatment of COVID-19. Additionally, remdesivir (Veklury) is an intravenous antiviral that has FDA approval for inpatient and outpatient treatment of COVID-19 in adult and pediatric patients 28 days and older weighing at least 3 kg.</p><p><strong>General Information on antivirals</strong><br></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://www.covid19treatmentguidelines.nih.gov/therapies/antiviral-therapy/summary-recommendations/" target="_blank">Antiviral Therapy Summary Recommendations | COVID-19 Treatment Guidelines (nih.gov)</a></p></li><li><p><a href="https://www.covid19treatmentguidelines.nih.gov/therapies/antiviral-therapy/table--characteristics-of-antiviral-agents/" target="_blank">Table 2f: Characteristics of Antiviral Agents | COVID-19 Treatment Guidelines (nih.gov)</a></p></li></ul><p><strong>Nirmatrelvir/ritonavir (Paxlovid):</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://www.fda.gov/media/155049/download" target="_blank">Paxlovid EUA Letter of Authorization</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/155050/download" target="_blank">Paxlovid Healthcare Provider Fact Sheet</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/155071/download" target="_blank">Paxlovid Dear Healthcare Provider Letter</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/155052/download" target="_blank">Paxlovid EUA Frequently Asked Questions</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/155072/download" target="_blank">Paxlovid Dispensing Information for Patients with Moderate Renal Impairment</a>Ā (PDF)</p></li><li><p><a href="https://www.covid19treatmentguidelines.nih.gov/therapies/antiviral-therapy/ritonavir-boosted-nirmatrelvir--paxlovid-/paxlovid-drug-drug-interactions/" target="_blank">NIH Paxlovid drug info</a></p></li><li><p><a href="https://www.covid19treatmentguidelines.nih.gov/therapies/antiviral-therapy/ritonavir-boosted-nirmatrelvir--paxlovid-/paxlovid-drug-drug-interactions/" target="_blank">NIH Paxlovid drug-drug interactions</a></p></li><li><p><a href="https://www.pfizermedicalinformation.com/en-us/drug-interaction-checker?product=PAXLOVID%E2%84%A2+%7c+nirmatrelvir+tablets%3b+ritonavir+tablets" target="_blank">Pfizer Paxlovid Drug Interaction Checker</a></p></li><li><p><a href="https://covid19-sciencetable.ca/sciencebrief/nirmatrelvir-ritonavir-paxlovid-what-prescribers-and-pharmacists-need-to-know-2-0/" target="_blank">Ontario COVID-19 Science Advisory Table</a></p></li><li><p><a href="https://www.fda.gov/media/158165/download" target="_blank">Paxlovid Patient Eligibility Screening Checklist Tool for Prescribers</a>Ā (PDF)</p></li><li><p><a href="https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/management-of-drug-interactions-with-nirmatrelvirritonavir-paxlovid/" target="_blank">Management of Drug Interactions With Nirmatrelvir/Ritonavir (PaxlovidĀ®): Resource for Clinicians (idsociety.org)</a></p></li><li><p><a href="https://emergency.cdc.gov/han/2022/pdf/CDC_HAN_467.pdf?ACSTrackingID=USCDC_511-DM82753&ACSTrackingLabel=HAN%20467%20-%20COCA%20Subscribers&deliveryName=USCDC_511-DM82753">CDC Health Alert Network (HAN) Health Advisory: COVID-19 Rebound after Paxlovid Treatment</a>Ā (PDF)</p></li></ul><p><strong>Molnupiravir (Lagevrio):</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://www.fda.gov/media/155053/download" target="_blank">Lagevrio EUA Letter of Authorization</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/155054/download" target="_blank">Lagevrio Healthcare Provider Fact Sheet</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/155101/download" target="_blank">Lagevrio Dear Healthcare Provider Letter</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/155056/download" target="_blank">Lagevrio EUA Frequently Asked Questions</a>Ā (PDF)</p></li><li><p><a href="https://www.fda.gov/media/155118/download" target="_blank">Lagevrio Prescriber Checklist</a>Ā (PDF)</p></li></ul><p><strong>Remdesivir (Veklury):</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://www.gilead.com/-/media/files/pdfs/medicines/covid-19/veklury/veklury_pi.pdf" target="_blank">Veklury Prescribing InformationĀ </a>Ā (PDF)</p></li><li><p><a href="https://www.vekluryhcp.com/downloads/Outpatient_Product_Information_Guide.pdf" target="_blank">Veklury Outpatient Product Information GuideĀ </a>(PDF)</p></li><li><p><a href="https://www.gilead.com/-/media/gilead-corporate/files/pdfs/covid-19/dhcp-letter_peds-labeling.pdf?la=en&hash=EBD10EB91622F6D797DC49C813FE7E01" target="_blank">Veklury Dear Healthcare Provider Letter</a>Ā (PDF)<br></p></li><li><p><a href="https://www.vekluryhcp.com/downloads/Coding_and_Reimbursement_information.pdf" target="_blank">Veklury Coding and Reimbursement information</a>Ā (PDF)<br></p></li></ul><p><br></p> | | | |
| Guidance on Monoclonal Antibodies | | 179 | | Guidance on Monoclonal Antibodies | <p>āāāāāMonoclonal antibodies are synthetic proteins that block virus from attachment and entry into human cells.Ā <span data-contrast="none" lang="EN-US">Due to resistance patterns of currently circulating subvariants in the United States, there are no anti-SARS-CoV-2 monoclonal antibody agents authorized for COVID-19 treatment or pre-exposure prophylaxisĀ at this time.</span>Ā <br></p><p><strong>General information on monoclonal antibodies:</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://www.covid19treatmentguidelines.nih.gov/therapies/anti-sars-cov-2-antibody-products/anti-sars-cov-2-monoclonal-antibodies/" target="_blank">Anti-SARS-CoV-2 Monoclonal Antibodies | COVID-19 Treatment Guidelines (nih.gov)</a><br></p></li></ul><p><strong>Infusion locations</strong><br></p><ul><li><p><a href="https://covid-19-therapeutics-locator-dhhs.hub.arcgis.com/" target="_blank">COVID-19 Therapeutics Locator (arcgis.com)</a></p></li></ul><p><strong>Bebtelovimab:</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://aspr.hhs.gov/COVID-19/Therapeutics/updates/Pages/important-update-30November2022.aspx">Bebtelovimab Not Authorized in US | Important Update | HHS/ASPR</a><br></p></li></ul><p><strong>COVID-19 Pre-exposure ProphylaxisĀ </strong><br></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><a href="https://aspr.hhs.gov/COVID-19/Therapeutics/Products/Evusheld/Pages/default.aspx">āEvusheld Not Authorized in US| Important Update | HHS/ASPRĀ ā</a>ā<br></li><li><p><a href="https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html?ACSTrackingID=USCDC_2067-DM81188&ACSTrackingLabel=COVID-19%20Preventive%20Medication&deliveryName=USCDC_2067-DM81188#preventive" target="_blank">COVID-19 Preventive Medication</a>ā<br><br></p></li></ul><p><br></p> | | | |
| Pre-Exposure Prophylaxis | | 178 | | Pre-Exposure Prophylaxis | <p>āāThere are currently no FDA approved or authorized treatments for pre-exposure prophylaxis against COVID-19.<br><br></p> | | | |
| Treatments for Post-COVID Conditions | | 193 | | Treatments for Post-COVID Conditions | <p>ā<span data-contrast="none" lang="EN-US">āāāāMedical providers will first rule out other medical conditions that could be causing symptoms. They might also run tests to understand which organs are affected such as the brain, nervous system, heart, or lungs. You may be referred to a specialist. Your medical provider may recommend treatments for your symptoms.Ā </span></p><p><span data-contrast="none" lang="EN-US">For example:</span><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}">Ā </span></p><div><div><ul><li><p><span data-contrast="none" lang="EN-US">Breathing exercises and respiratory therapy can help the lungs recover.</span><span data-ccp-props="{"134233279":true,"201341983":0,"335559739":160,"335559740":259}">Ā </span></p></li><li><p><span data-contrast="none" lang="EN-US">Physical and occupational therapy can help patients get strong enough to return to their daily activities and work. Pacing yourself and not overdoing it is also important.</span><span data-ccp-props="{"134233279":true,"201341983":0,"335559739":160,"335559740":259}">Ā </span></p></li><li><p><span data-contrast="none" lang="EN-US">Counseling or psychotherapy can help patients and loved ones with the mental and emotional effects of COVID-19 and post-COVID conditions.</span><span data-ccp-props="{"134233279":true,"201341983":0,"335559739":160,"335559740":259}">Ā </span></p></li></ul></div><div><p><span data-contrast="none" lang="EN-US">See the "Tools for recovery and rehabilitation" section on the <a href="/Programs/CID/DCDC/Pages/COVID-19/Post-COVID-Conditions-Resources.aspx">Resources for People with post-COVID Conditions (Long COVID)</a> webpage for more information.Ā </span><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":259}">Ā </span></p></div></div> | | | |
| Locating COVID-19 Therapeutics | | 182 | | Locating COVID-19 Therapeutics | <p>āāHHS maintains a Therapeutic locator of sites that currently have outpatient therapeutics available.</p><p>The federal government launched the Test to Treat initiative to facilitate expedited access to testing, assessment, and treatment. Through this program, various clinic-based pharmacies provide on-site testing (including the evaluation of at-home test results), clinical assessment, and prescription and dispensing of COVID-19 oral antiviral medications.</p><p>Additionally, the California Department of Public Health (CDPH) and Optum Serve are upgrading testing sites to provide free and confidential testing and oral antiviral treatment to individuals who test positive and are eligible for COVID-19 treatment, including for uninsured, underinsured, undocumented, and unhoused individuals.</p><p><strong>Therapeutics locator</strong></p><ul><li><p><a href="https://covid-19-therapeutics-locator-dhhs.hub.arcgis.com/" target="_blank">COVID-19 Therapeutics Locator (arcgis.com)</a></p></li></ul><p><strong>Test to Treat Program ā General Information</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://aspr.hhs.gov/TestToTreat/Pages/default.aspx" target="_blank">Test To Treat (hhs.gov)</a></p></li><li><p><a href="https://aspr.hhs.gov/TestToTreat/Documents/Fact-Sheet.pdf" target="_blank">Fact Sheet: COVID-19 Test to Treat (hhs.gov)</a>Ā (PDF)</p></li><li><p><a href="https://aspr.hhs.gov/TestToTreat/Pages/digital-toolkit.aspx" target="_blank">Test to Treat Digital Toolkit</a></p></li></ul><p><strong>Test to Treat Site Locator</strong></p><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li><p><a href="https://covid-19-test-to-treat-locator-dhhs.hub.arcgis.com/" target="_blank">COVID-19 Test to Treat Locator English (arcgis.com)</a></p></li><li><p><a href="https://lhi.care/start" target="_blank">COVID-19 Test Registration (lhi.care)</a></p></li></ul><p><strong>CDPH Test to Treat Locations</strong></p><ul><li><p><a href="/Programs/CID/DCDC/Pages/COVID-19/Test-to-treat-locations.aspx" target="_blank">COVID-19 Test to Treat Locations</a><br></p></li></ul> | | | |
| Increasing Equitable Access | | 304 | | Increasing Equitable Access | <p>āāāFor an overview of California's commitment to health equity in the COVID-19 response, please visit theĀ <a href="https://covid19.ca.gov/equity/">California for All COVID-19 equity page</a> (ca.gov).ā<br></p><p>Please use the below guidance to increase equity in access toĀ COVID-19 treatments. <strong>Please note that theĀ COVID-19 Uninsured GroupĀ Program will expire on May 31, 2023.Ā </strong></p><p>Best practices for caring for uninsured patients and/or a patient new to your clinic or system:<br></p><div><ul><li>Lower barriers to seek urgent care for evaluation and treatment for COVID-19, including shortening or bypassing standard enrollment processes.Ā </li><li>Become a Medi-Cal Qualified Provider to access the COVID-19 Uninsured Group Program. This program allows uninsured patients get coverage for their COVID-19 care.</li><ul><li>Step 1: Make sure you are a Medi-Cal provider (in some cases you may also need to be a provider for a separate Health Access Program). Information about how to sign up as a Medi-Cal provider can be found at the <a href="https://www.dhcs.ca.gov/provgovpart/Pages/PAVE.aspx">Provider Application and Validation for Enrollment</a> (PAVE) page on the DHCS website</li><li>Step 2: Become a COVID-19 Uninsured Group Qualified Provider by enrolling in any of the following Presumptive Eligibility programs. **Note: you do not need to treat the specific populations listed in these programs in order to become a Qualified Provider.**Ā </li><ul><li>Hospital Presumptive EligibilityĀ </li><ul><li><a href="https://www.dhcs.ca.gov/services/medi-cal/eligibility/Pages/HospitalPE.aspx">Hospital Presumptive Eligibility (HPE): Provider Enrollment InstructionsĀ </a>PDF<br></li><li><a href="https://files.medi-cal.ca.gov/pubsdoco/Publications/masters-other/ACA/Hospital_PE_Provider_Form_Agreement_DHCS7012.pdf">Hospital Presumptive Eligibility (HPE) Program Provider Election Form and Agreement</a>Ā PDF<br></li></ul><li>Presumptive Eligibility for Pregnant Women</li><ul><li style="text-align:left;"><a href="https://files.medi-cal.ca.gov/pubsdoco/publications/masters-mtp/part2/presumprov.pdf">Presumptive Eligibility for Pregnant Women Provider Enrollment Instructions</a>Ā PDF<br></li><li><a href="https://files.medi-cal.ca.gov/pubsdoco/publications/masters-other/ACA/Qualified_Provider_Agreement-MC_311-2_21_17.pdf">Qualified Provider Application and Agreement for Participation in the Presumptive Eligibility for Pregnant Women (PE4PW) Program</a>Ā PDF<br></li></ul><li>Child Health and Disability Prevention (CHDP)<br></li><ul><li><a href="https://files.medi-cal.ca.gov/pubsdoco/publications/masters-mtp/part2/epsdtchdp.pdf">CāHDP Program</a>Ā PDF<br></li></ul></ul><li>Step 3: Once you are a Qualified Provider of the COVID-19 Uninsured Group, assist uninsured patients to enroll into the COVID-19 Uninsured Group. (Patient applicants do not have direct access to the portal which is only available to Qualified Providers)Ā </li><ul><li>Option 1: Paper transcription</li><ul><li>Download a paper version of the application at: <a href="https://www.dhcs.ca.gov/services/medi-cal/eligibility/Documents/MC-374-COVID-19-Uninsured-Group-Application-09-2020.pdf">MC 374 Application for Coverage of Coronavirus (COVID-19) Testing Costs</a>Ā PDF<br></li><li>Have the patient fill out the application</li><li>Transcribe the individualās information directly into the COVID-19 Uninsured Group Application Web Portal (<a href="https://files.medi-cal.ca.gov/pubsdoco/publications/misc/User_Guide_COVID19_Uninsured_Group.pdf">COVID-19Ā Uninsured Gāroup Application Web Portal User Guide</a>Ā PDF)Ā based on their answers to the paper applicationĀ </li></ul><li>Option 2: Online entry with patient</li><ul><li>Navigate to the COVID-19 Uninsured Group Application Web Portal (<a href="https://files.medi-cal.ca.gov/pubsdoco/publications/misc/User_Guide_COVID19_Uninsured_Group.pdf">COVID-19 Uninsured Group Application Web Pāortal User Guide</a>Ā PDF) with the patient in the room. Providers can log into the online portal using the user guide provided</li><li>Fill out the application based on the patientās verbal answers</li></ul></ul><li>After the application is submitted online, the eligibility results are immediate (approval or denial).Ā Providers will be able to see a real-time eligibility response on their web browser.</li><li>A Medi-Cal ID number is generated for the patient which can then be used for billing and claims.</li><li>For more information, see: <a href="https://www.dhcs.ca.gov/services/medi-cal/eligibility/Pages/COVID-19-Presumptive-Eligibility-Program.aspx">COVID-19 Uninsured Group Program</a> (ca.gov)Ā <br></li></ul><li>Follow-Up: Provide for follow-up with the member/patient to confirm access to therapeutics and address questions or concerns about side effects</li><li>Equity and Reporting: Develop metrics and tracking systems to regularly review COVID-19 utilization data, identify disparities to help prioritize resources. Example metrics include:</li><ul><li>Time from symptom onset to receipt of therapeutic</li><li>Time from initial contact with member to receipt of therapeutic</li><li>Member demographics accessing treatment, including: SDOH, race, ethnicity, zip code, and age</li><li>Percent of symptomatic and COVID-19 positive patients that are evaluated by a prescriber</li><li>Percent of symptomatic and COVID-19 positive patients that receive a prescription for a therapeuticĀ <br></li><li>Reasons why a patient was not prescribed a therapeuticā<br></li></ul></ul></div> | | | |
| Allocation and Distribution of Therapeutics | | 183 | | Allocation and Distribution of Therapeutics | <p>ā<br></p><p></p><div>The U.S. Department of Health and Human Services (HHS) currently manages a state/territory-coordinated distribution system for COVID-19 therapeutic oral antiviral products under EUA.Ā <br></div><div><br></div><div>HHS uses a weekly "threshold and replenishment" strategy to provide allocations to each state, territory, the District, and federal partners. Each partner gets a threshold for nirmatrelvir/ritonavir (Paxlovid) and molnupiravir (Lagevrio), and each Monday the federal government replenishes products up to the weekly threshold.Ā <br></div><div><br></div><div>The California Department of Public Health (CDPH) is allocating COVID-19 therapeutics active against current variants and included in the HHS jurisdictional distribution system using the below strategies:<br><br></div><div><div><div><table cellspacing="0" width="100%" class="ms-rteTable-default"><tbody><tr class="ms-rteTableEvenRow-default"><td class="ms-rteTableEvenCol-default" style="width:33.3333%;"><span class="ms-rteThemeForeColor-5-0"><span><strong>āPrāoduct</strong></span><br></span></td><td class="ms-rteTableOddCol-default" style="width:33.3333%;"><span class="ms-rteThemeForeColor-5-0"><span><strong>āAuthorized Indication</strong></span><br></span></td><td class="ms-rteTableEvenCol-default" style="width:33.3333%;"><span class="ms-rteThemeForeColor-5-0"><strong>āAllocation Strategy</strong></span><br></td></tr><tr class="ms-rteTableOddRow-default"><td class="ms-rteTableEvenCol-default">ā<strong>nirāāāāmatrelvir/ritoāāāāāāāāānavir (Paxlovid)Ā </strong><div>Oral protease inhibitor</div><div>&</div><div><strong>molnupiravir (Lagevrio)</strong></div><div>Oral nucleoside analogue<br></div><div><br><br></div><br></td><td class="ms-rteTableOddCol-default">āTreatment of mild to moderately ill outpatients with current diagnosis of COVID-19<br></td><td class="ms-rteTableEvenCol-default">āAllocated to counties based on new COVID-19 cases (7-day average) and <a href="https://www.healthyplacesindex.org/">Healthy Places Index</a> (HPI); with 50% weighted to cases and 50% weighted to HPI. Within the 50% allocated by HPI, 40% to Q1 (most disadvantaged); 30% to Q2; 20% to Q3; 10% to Q4 (most advantaged).<br></td></tr></tbody></table></div></div><br><div>Additionally, the federal <a href="https://aspr.hhs.gov/testtotreat/Pages/default.aspx">Test to Treat program</a> allows for individuals to receive testing, assessment, and treatment all in one location. The Administration for Strategic Preparedness and Response (ASPR) distributes the oral antiviral products directly to Test to Treat pharmacy-based clinics, health centers, and long-term care facilities. Certain providers within the state allocation program are also participants in the Test to Treat Program. For more information, please refer to <a href="https://aspr.hhs.gov/TestToTreat/Documents/Fact-Sheet.pdf">ASPR's Test to Treat fact sheet</a> (PDF) or the <a href="https://covid-19-test-to-treat-locator-dhhs.hub.arcgis.com/">ASPR Test to Treat map</a> for a list of all Test to Treat sites.Ā <br></div><div><br></div><div><span class="ms-rteStyle-Accent1"><strong>Ordering COVID-19 Therapeutics</strong></span><br></div><div><br></div><div>Facilities that are able to operationalize COVID-19 therapeutics and would like to be considered for product allocations should contact their <a href="https://emsa.ca.gov/medical-health-operational-area-coordinator/">Medical and Health Operational Area Coordinator</a> (MHOAC).<br></div><div><br></div><div>Remdesivir is not being allocated by the federal government and can be <a href="http://www.wsha.org/wp-content/uploads/AmerisourceBergen-Remdesivir-Distribution.pdf">purchased </a>(PDF) directly from the distributor.<br></div><div><br></div><div><span class="ms-rteStyle-Accent1"><strong>ResourcesĀ </strong></span><br></div><div><br></div></div><ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;background-color:#ffffff;"><li style="box-sizing:border-box;"><p><a href="https://aspr.hhs.gov/COVID-19/Therapeutics/updates/Documents/ASPR-Fact-Sheet_Therapeutics-Utilization.pdf" target="_blank">ASPR Therapeutics Distribution fact sheet</a>Ā (PDF)</p></li><li style="box-sizing:border-box;"><p><a href="https://aspr.hhs.gov/COVID-19/Therapeutics/Orders/Pages/default.aspx" target="_blank">COVID-19 Therapeutics Thresholds, Orders, and Replenishment by Jurisdiction | HHS/ASPR</a><br></p></li><li style="box-sizing:border-box;"><div style="color:#444444;background-color:rgba(255, 255, 255, 0.85);"><a href="https://covid-19-test-to-treat-locator-dhhs.hub.arcgis.com/">HHS/ASPR COVID-19 Test to Treat Locator English</a> (arcgis.com)<br></div></li></ul><p><br></p> | | | |
| Information for Pharmacists | | 303 | | Information for Pharmacists | <p>āāāPharmacists can use the<a href="https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/COVID-19/Resource-Guide-for-Pharmacies-to-Prevent-Delayed-COVID-19-Treatment.aspx"> Resource Guide for Pharmacies to Prevent Delayed COVID-19 Treatmentā</a> for guidance regarding best practices for prescribing and dispensing COVID-19 therapeutics.ā</p> | | | |
| Billing Information | | 184 | | Billing Information | <ul style="box-sizing:border-box;margin-top:0px;margin-bottom:10px;color:#202020;font-family:"source sans pro", sans-serif;font-size:15px;background-color:#ffffff;"><li><p>āā<a href="https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/covid-19-vaccines-and-monoclonal-antibodies" target="_blank">CMS reimbursement information for monoclonal antibodies</a><br></p></li><li><p><a href="https://www.cms.gov/files/document/hpms-memo-oral-antiviral-guidance.pdf" target="_blank">CMS reimbursement information for oral antivirals</a><br></p></li></ul><p><br></p> | | | |