The Biden Administration ended the COVID-19 Public Health Emergency (PHE) on May 11, 2023. This marks over 3 years since the Public Health Emergency (PHE) was first enacted in January of 2020. While the COVID-19 pandemic may seem to be a distant memory to some, it was attributed to nearly 7 million deaths worldwide, including nearly 1.2 million deaths in the US. COVID-19 cases seem to be fewer and milder for now, but many people are still struggling with long COVID repercussions and high-risk populations need to continue to be careful. As we unwind from some of the policies that were in place during the PHE, we’ll try to answer some of the questions that may arise on how this will affect health benefits, vaccines, tests, and treatments that were approved during the public health emergency.
The Trump administration declared a Public Health Emergency (PHE) pursuant to section 319 of the Public Health Service Act on Jan 27, 2020. Since the initial PHE declaration, the Section 319 PHE has been consecutively extended every 90 days. Shortly after the initial PHE declaration, on February 4, 2020, the Secretary of HHS declared a PHE pursuant to section 564 of the FD&C Act to allow issuance of Emergency Use Authorizations (EUAs) for vaccines, treatments, and tests during the COVID-19 pandemic. On March 13, 2020, the Trump Administration declared a national emergency pursuant to section 201 of the National Emergencies Act.
Jump to 2023, President Biden terminated the COVID-19 national emergency on April 10, 2023. Subsequently, the Section 319 PHE was allowed to expire on May 11, 2023. This was the provision that required COVID-19 coverage of vaccines, testing, and treatments without cost sharing.
Where are we now?
The first thing to note is that the expiration of the Section 319 PHE does not impact any of the vaccines, treatments and tests authorized through Emergency Use Authorizations (EUAs), nor will it affect the FDA’s ability to issue future EUAs for COVID-19 products. The issuance of EUAs were allowed under a separate PHE pursuant to section 564 of the FD&C Act and will remain in effect until it is terminated by the HHS Secretary.
Insurers and group health plans will no longer be required to cover COVID-19 diagnostic testing, including the OTC at-home tests without cost sharing. Medicare participants will no longer receive free, at-home tests. However, laboratory-conducted COVID-19 tests will continue to be covered without cost-sharing when ordered by a provider. Medicaid participants will still have their at-home tests covered at no-cost through September 2024. Afterwards, home test coverage will vary by state.
Type of Tests
- Molecular Tests
- PCR, nucleic acid amplification tests (NAATs), and other molecular amplification tests detect the virus’s genetic material.
- Sent to a laboratory and processed in approximately 48 hours.
- Most accurate test
- Antigen Tests
- Also referred to as rapid tests
- Convenient self-test
- FDA currently lists 35 different OTC tests
- Three COVID-19 vaccines are currently approved or authorized in the United States:
- Pfizer-BioNTech (mRNA vaccine)
- Moderna (mRNA vaccine)
- Novavax (traditional vaccine)
- Janssen COVID-19 vaccine has been discontinued in the US
Access to COVID-19 vaccines will continue to be offered at no cost until the government supply runs out. The US government has not announced any plans to purchase additional COVID-19 vaccines so once supply runs out, which we anticipate will occur in late 2023, payers will be responsible for the cost to purchase these vaccines. Due to the Affordable Care Act and other recent legislation, even after the government supply has run out, preventative drugs such as COVID-19 vaccines will continue to be free of charge to most people with private and public insurance as long as they receive the vaccine from an in-network provider. Plans may elect to not cover these vaccines if they are administered out of network. Pfizer and Moderna are expected to raise the cost of their COVID-19 vaccines when they move from government supply to the commercial market. It is expected that the Pfizer and Moderna vaccines may cost between $110 to $130 per dose. The CDC recommends at least although some age groups may require additional doses to be considered up to date.
Current US Vaccination Rates
- People with at Least 1 Dose (Age 5+ Years) – 85.8%
- Fully Vaccinated People (Age 5+ Years) – 73.4%
- People with an Updated Booster (Age 5+ Years) – 17.8%
Medicare Part B will continue to cover the COVID-19 vaccines without cost-sharing. COVID-19 vaccines are ACIP (Advisory Committee on Immunization Practices) recommended vaccines, so Medicaid and CHIP (Children’s Health Insurance Program) are required to cover these vaccines with no cost sharing.
- FDA-approved Treatments
- Actemra (tocilizumab) – treatment of COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
- Veklury (remdesivir) – treatment of COVID-19 in adults and pediatric patients (28 days of age and older and weighing at least 3 kilograms) who are: hospitalized, or not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
- Olumiant (baricitinib) – treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
- Paxlovid (nirmatrelvir and ritonavir) – treatment of mild-to-moderate COVID-19 in people 18 years and older who are at high risk for progression to severe COVID-19, including hospitalization or death.
- Emergency Use Authorized (EUA) Products
- Paxlovid (nirmatrelvir and ritonavir) – treatment of mild-to-moderate COVID-19 in people 12 thru 17 years who are at high risk for progression to severe COVID-19, including hospitalization or death.
- Lagevrio (molnupiravir) – treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom other COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.
- Kineret (anakinra) – treatment of COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR).
- Olumiant (baricitinib) – treatment of COVID-19 in hospitalized pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygen (ECMO).
- Actemra (tocilizumab) – treatment of COVID-19 in hospitalized pediatric patients 2 to less than 18 years of age who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
- Gohibic (vilobelimab) – treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO).
COVID-19 treatments will now be subject to cost sharing like other drugs with traditional coverage for commercial health plans. Medicare Part D plans will continue to cover drugs authorized under the EUA. Drugs not approved by the FDA were not covered by Part D plans until policies were changed during the pandemic to allow coverage of drugs authorized under the EUA. Part D enrollees may face variable cost sharing amounts based on their specific plan. Medicaid and CHIP will continue to cover all COVID-19 treatments with no cost sharing through September 30, 2024. After which, FDA-approved treatments will still be covered but could be subject to cost sharing. Coverage of treatments that are authorized under the EUA will vary by state.
Some of the COVID-19 treatments were purchased and supplied by the government. With the ending of the PHE, funding for these treatments have run out. Once government supplies run out, the cost of COVID-19 treatments will be incurred by payers. Veklury (remdesivir) is not currently covered through government funding. The current cost of $2,750 for a 5-day treatment cycle is expected to remain the same through 2023. It is not known how much Lagevrio will cost once government supplies run out, but chances are it will be more than its current government contract price of $700 per 5-day treatment course.
On May 25, 2023, Paxlovid became the first oral COVID-19 treatment approved by the FDA. Originally granted EUA in December 2021 to treat mild to moderate COVID-19 in adults and pediatric patients 12 years and older, Paxlovid is now FDA approved to treat mild to moderate COVID-19 in adults who are at high risk for progression to severe disease. Paxlovid is still authorized to treat pediatric patients 12 years or older under the EUA. The US government has supplied and covered the cost of Paxlovid to date. Once government supplies and funds run out, it is expected the cost of this drug will transition to commercial, Medicare, and Medicaid payers over time. We anticipate the government supply will run out sometime in the second half of 2023. New NDCs for the commercially available product will help payers distinguish it from the government supply. The government contracted cost of Paxlovid is around $530 per treatment course. The cost is expected to increase as Paxlovid transitions to the private market.
We’ve come a long way since the start of the pandemic where lockdowns, closing of businesses, and quarantines seemed to be the norm. Government policies and funding paved the way for discovery of new vaccines and treatments at unprecedented speeds. Much was accomplished during the pandemic, but there is still work to be done as we move past the PHE. As payers transition from some of the policies that were in place during the PHE, they must do so in a way that protects and informs their members about changes to their benefits while continuing to provide access to COVID-19 testing, vaccines, and treatments.