Last updated on August 2, 2024.
Outpatient COVID-19 treatments can help prevent severe illness for some people who get infected with COVID-19, are not hospitalized, and have one or more risk factors for progression to severe disease. Those with risk factors include older adults (especially those ages 65 years or older, with risk increasing with advancing age), people who are unvaccinated or are not up to date on their COVID-19 vaccinations, and people with certain medical conditions, such as chronic lung disease, heart disease, or a weakened immune system. Additional risk factors are social and environmental conditions called social determinants of health. Health care providers should promptly evaluate all people who have symptoms of COVID-19 for treatment. Early evaluation by a health care provider is important because these medications are most effective when given within days of when symptoms begin.
Medication to treat COVID-19 is not a substitute for vaccination. Getting vaccinated against COVID-19 and staying up to date is the best way to keep from getting sick with COVID-19. Encourage patients to get their COVID-19 vaccine as recommended.
Essential information for therapeutics providers
When prescribing outpatient COVID-19 therapeutics for patients diagnosed with COVID-19 (either via testing or clinically*), consider:
- COVID-19 can vary from asymptomatic infection to critical illness. Symptoms and severity can change during illness.
- Information about clinical management and treatment of COVID-19 is categorized by severity of illness.
- Most patients with mild or moderate COVID-19 can be managed in an outpatient setting with authorized treatment for those at risk of severe illness.
- Most patients with severe or critical COVID-19 require hospitalization.
*FDA recognizes that, in rare instances, people with a recent known exposure (e.g., a household contact) who develop signs and symptoms consistent with COVID-19 may be diagnosed by their health care provider as having COVID-19 even if they have a negative direct SARS-CoV-2 viral test result. In such instances, their health care provider may determine if treatment is appropriate.
Treatment guidelines for special populations can be found on CDC’s Clinical Considerations for Special Populations. Included populations are people who are moderately or severely immunocompromised, pregnancy and recent pregnancy and pediatric populations. Pediatric providers can find additional information on CDC’s Information for Pediatric Healthcare Providers COVID-19 page.
CDC has guidance on COVID-19 Treatment Clinical Care for Outpatients, which outlines the current available options, treatment indications, and additional prescribing information (e.g. dosing, contraindications).
Providers should consider what medications a patient is taking and the presence of renal or hepatic† disease. Providers can check for drug interactions using the Liverpool COVID-19 Drug Interactions Checker. Providers should consider the magnitude and significance of the potential drug-drug interaction when choosing a management strategy. Potential strategies include:
- Increasing monitoring for potential adverse events to the concomitant medication.
- Adjusting the dose of the concomitant medication.
- Temporarily withholding the concomitant medication.
- Using an alternative to the concomitant medication.
- Using alternative COVID-19 therapies.
Consider consulting with an expert (e.g., a pharmacist or the patient’s specialist providers) when treating patients who are receiving highly specialized therapies or drugs that are prone to concentration-dependent toxicities, such as certain anticonvulsant, anticoagulant, immunosuppressant, antiarrhythmic, chemotherapeutic, and neuropsychiatric drugs.
COVID-19 therapeutics are now available on the commercial market and must be ordered directly from the manufacturers. Providers should order COVID-19 therapeutics and/or pre-exposure prophylaxis through their usual medication ordering channels.
To learn more about the commercialization of COVID-19 therapeutics, see the U.S. Department of Health & Human Services’ webpages Sunsetting the U.S. Government COVID-19 Therapeutics Distribution Program and COVID-19 Therapeutics Transition to Commercial Distribution: Frequently Asked Questions.
Patient assistance programs providing low and no-cost access to COVID-19 therapeutics are available to patients who are underinsured, uninsured, and who are on Medicare or Medicaid. Patients should enroll in a program to learn if they can receive assistance for specific medications, regardless of their insurance status. Providers and clinicians should review the commercialization guide for more information on ordering and distribution timelines and patient assistance programs. Although listings may not be complete, COVID-19 medications can be located online.
In February 2024, CMS issued a memo about Medicare Beneficiary Coverage Pathways for Commercial Oral Antivirals for COVID-19.
Figure from CMS:
As the U.S. Department of Health and Human Services (HHS) is no longer distributing COVID-19 therapeutics, except to certain federal entities, ASPR asked that all providers finalize their reporting data in the Health Partner Ordering Portal (HPOP) by June 30, 2024. Federal entities that are receiving HHS-distributed oral antivirals must continue to report that inventory.
Additional information can be found on the ASPR COVID-19 Therapeutics HHS Distribution Program Closeout Activities and ASPR Product Resources. Email COVID19Therapeutics@hhs.gov with any further questions.
Voluntary reporting of therapeutics inventory to USG is a mechanism for providers to report commercial treatment location data that will be visible in an enhanced treatments locator tool. HPoP users can use their existing account for voluntary reporting. Non-HPoP users can access the HPoP Voluntary Reporting site.
The prescribing health care provider and/or designee must report all medication errors and serious adverse events potentially related to these medications to Medwatch: The FDA Safety Information and Adverse Event Reporting Program. Reports must be filed within seven calendar days from the health care provider's awareness of the event.
Information on FDA shelf life extensions and expirations can be found on FDA’s Expiration Dating Extension webpage, as well as the ASPR product expiration webpage. Email COVID19Therapeutics@hhs.gov with any questions.
In general, USG-distributed therapeutics are the property of USG and must be used in accordance with the FDA approval or FDA Emergency Use Authorization (EUA). USG-distributed therapeutics may not be donated or otherwise used outside the United States. Check expiration dates on ASPR’s website before disposing of therapeutics. ASPR provides guidance on inventory and disposal management.
Clinical educational resources on therapeutics may be found on CDC’s webpage COVID-19 Treatment Clinical Care for Outpatients. Email cdphe_covid_med_guidance@state.co.us with any questions.
The ASPR/HHS Test to Treat program is a community health program that aims to offer free and low-cost COVID-19 health services nationwide.
A physician referral is not required for a patient to be seen at a Test to Treat location. While Test to Treat sites are required to see patients regardless of insurance status, there may be provider evaluation or pharmacy dispensing fees. Insurance may or may not cover all or some of these fees. Find locations offering Test to Treat.
Facilities should make a plan now with each resident’s health care team to access treatment options if the resident tests positive for COVID-19. Keep up-to-date medication lists and ask their health care team if there are any drug interactions or necessary modifications with COVID-19 medications. Working with health care providers in advance to determine the best course of action can help prevent delayed treatment, especially if a resident gets sick on a weekend or over a holiday. Also discuss treatments with your residents and residents’ decision makers now. This conversation can be used to obtain consent for treatment in case a resident tests positive for COVID-19.
Find the closest pharmacy to the resident carrying COVID-19 therapeutics so you can easily provide this information to the prescribing provider. This webpage and ASPR’s COVID-19 Treatments: Information for Long‑Term Care Facilities webpage include information on availability and use of COVID-19 treatments for outpatients with mild-to-moderate COVID-19.
The COVID-19 Medical Epidemiology Unit is available for consultations with facility medical directors and/or resident health care providers about therapeutics. Email cdphe_covid_med_guidance@state.co.us for more information.