HHS Procures Federally-Covered COVID-19 Treatment Doses For Uninsured

The US Department of Health and Human Services (HHS) will cover doses of the coronavirus monoclonal antibody treatment bebtelovimab for the uninsured and underinsured, the department announced.

HHS is securing 60,000 doses of the drug in order to replace commercial doses used to cure uninsured and underinsured patients. Bebtelovimab is mostly used for patients who test positive for coronavirus and who are at high risk for severe coronavirus symptoms including hospitalization but cannot use other existing, authorized treatments.

Bebtelovimab was free during the pandemic but has been transitioned to the commercial market as of August 17. The federal government phased out distribution of the drug in the time leading up to this transition.

However, providers still sometimes use the commercial drug for patients without commercial coverage. While Medicare, Medicaid, and most commercial plans cover bebtelovimab, individuals without insurance or those who are underinsured would not receive federal coverage for the drug once it became a commercial drug.

In order to support Americans’ access to treatment, the department is offering 60,000 doses of the drug to supplement the commercial drugs that providers give the uninsured or underinsured. Providers can use their typical metrics to assess uninsurance or underinsurance.

With approximately eight percent of Americans lacking health insurance coverage, HHS projected that the store of 60,000 drugs would last through September 2023.

Between February 2022 when the FDA granted emergency use authorization to bebtelovimab and August 2022 when the drug was phased into the commercial market, HHS purchased over 750,000 doses of bebtelovimab.

The US Food and Drug Administration (FDA) updated their letter of authorization for the drug on August 5, 2022, signaling that it was authorized for commercial distribution. Although bebtelovimab’s transition to the commercial marketplace was faster than expected, it was an anticipated move. HHS announced the transition on August 11, 2022.

“Bebtelovimab is transitioning to the commercial marketplace. To ensure there is no break in availability of bebtelovimab to states/territories and providers, HHS has coordinated with Lilly to enable the transition from US government distributed supply to commercially available supply,” an update from HHS explained.

“Lilly will make the product commercially available for purchase through a sole distributor, AmerisourceBergen, beginning the week of August 15th, prior to the end of distribution of the government’s supply.”

HHS announcement offered guidance on how Medicaid and Medicare covered the drug. At the time, Lilly and the federal government were still in discussions about how to cover the drug for under- and uninsured individuals. HHS advised providers to prioritize government-supplied doses for uninsured and underinsured patients.

Bebtelovimab is just one of many coronavirus-related treatments, tests, and vaccines that some experts fear may not be as accessible for uninsured and underinsured individuals as federal funding slows and when the public health emergency ends.

The Health Resources and Services Administration (HRSA) COVID-19 Uninsured Program is set to end without more funding. But the federal government has stopped providing funds for treatment, tests, and vaccines. Although individuals will still have access to free resources, safety net providers will not receive reimbursement for care delivered to uninsured individuals.

In some states, Medicaid expansion has helped alleviate costs as federal funding withdraws. But some of these coverage expansions will expire with the public health emergency.