By Christina Lavoie, Director of Policy, Health Industry Distributors Association
With the expiration of the COVID-19 Public Health Emergency (PHE), now is a good opportunity to review what changes the end of the PHE mean for the healthcare industry. The termination of the PHE was announced at the end of January to give healthcare providers and distributors adequate time to navigate the numerous authorities, waivers, and flexibilities that are set to expire.
Understanding the difference: PHE vs. EUA
The PHE is different from the Food and Drug Administration (FDA) Emergency Use Authorization (EUA) which allows FDA to fight threats by expediting the availability and use of medical countermeasures. The EUA authority allowed FDA to authorize diagnostic COVID tests, vaccines, and medical treatments to prevent serious illness in an efficient manner. Because EUAs are not dependent on a PHE, EUAs can remain in effect after the termination of the PHE. However, the FDA must provide advance notice of the termination of a EUA declaration in the Federal Register.
Impact on patients and providers
For providers, certain Medicare and Medicaid waivers and broad flexibilities for healthcare providers are no longer necessary. Hospitals will no longer receive a 20% payment bump for the treatment of patients diagnosed with COVID-19. Reporting of COVID-19 laboratory results and immunization data to the Centers for Disease Control and Prevention will change. At the end of the PHE, the Department of Health and Human Services will no longer have the express authority to require this data from labs. This may affect the reporting of negative test results and impact the ability to calculate the positivity rate for COVID-19 tests in some jurisdictions. However, EUAs issued by the FDA for COVID-19 products (including tests, vaccines, and treatments) will not be affected. Nor will telehealth flexibilities for both Medicare and Medicaid.
For patients, coverage for COVID-19 testing for Americans will change. Medicare beneficiaries will lose access to free over-the-counter (OTC) COVID-19 tests. However, for those enrolled in Part B, there will continue to be coverage without cost sharing for laboratory-conducted COVID-19 tests when ordered by a provider. The requirement for private insurance companies to cover COVID-19 tests without cost sharing, both for OTC and laboratory tests, will end. Access to COVID-19 vaccinations and certain treatments, such as Paxlovid and Lagevrio, will generally not be affected.
The formal end of the COVID-19 PHE is an opportunity to take stock of our nation’s commitment to public health preparedness. When COVID-19 was declared a pandemic more than three years ago, our industry faced a challenge of unprecedented scale and complexity. We rose to the occasion and answered the call of our country. Today, HIDA advocates for policies to strengthen the supply chain for the next health emergency.