On September 24, 2021, the owner of a pharmacy in Puerto Rico pleaded guilty to participating in a felony conspiracy to convert government property and to commit health care fraud in connection with the illegal vaccination of minors between the ages of 7 to 11 with the Pfizer-BioNTech COVID-19 vaccine. The U.S. Attorney’s Office (USAO) for the District of Puerto Rico and the Department of Health and Human Services, Office of Inspector General (HHS-OIG) announced both the charge and the plea on Monday. To the best of our knowledge, this is the first time anyone has been federally charged for administering the COVID-19 vaccine to an unauthorized population.
From approximately May 28, 2021 through June 22, 2021, the pharmacy owner and her employees conspired to knowingly and willfully administer the Pfizer-BioNTech COVID-19 vaccine to a total of 24 children aged 7-11 and to submit corresponding claims to the Pharmacy Benefit Manager (PBM) for Medicaid in Puerto Rico. A full dosage (30 µg) of the vaccine was administered to the children; no serious medical conditions have been identified to date as a result of the illegal vaccination. The Pfizer-BioNTech COVID-19 vaccine received emergency use authorization (EUA) for the prevention of COVID-19 disease in individuals aged 12-15 in May 2021. While Pfizer and BioNTech recently announced positive results from a pivotal trial of its COVID-19 vaccine in children ages 5-11, it has not yet received an EUA for this age group. Additionally, this recent trial studied a two-dose regimen of 10 µg administered 21 days apart, a much smaller dose than the 30 µg dose used for individuals 12 and older. The Pfizer-BioNTech COVID-19 vaccine, now marketed as Comirnaty, has received full approval for the prevention of COVID-19 disease in individuals 16 years of age and older, and is available under EUA for children 12-15.
The use of an approved drug for a use that was not approved by FDA, commonly known as “off-label” use, is typically a decision left to individual healthcare providers. However, that is not necessarily the case within the specific context of the COVID-19 vaccines. Currently, all COVID-19 vaccine used in the United States has been purchased by the government for administration exclusively by enrolled providers through the CDC COVID-19 Vaccination Program. Eligible pharmacies participating in the program must comply with all FDA requirements, including the vaccine’s EUA or approval. COVID-19 vaccines must be free to the patient, but vaccination providers may seek reimbursement for vaccine administration fees from the applicable private or public payor. By administering the vaccine to children aged 7-11, which is not an age group authorized under the EUA, the pharmacy illegally conspired to “convert” the government’s property (i.e., the vaccine itself). “Conversion” is a common law tort that may occur when one intentionally interferes with a person’s right to property without the owner’s consent and without lawful justification. By billing the PBM for the administration of the vaccine to an unauthorized population, the pharmacy committed health care fraud. In Monday’s statement, the USAO and HHS-OIG said that the unlawful activity was “identified quickly” by the Puerto Rico Department of Health.
Under the terms of the plea, the pharmacy owner voluntarily agreed to be excluded as a provider for Medicare, Medicaid, and all federal health care programs for a period of five years. She also faces a maximum penalty of 5 years in prison, a fine of up to $250,000, and 3 years of supervised release. The pharmacy itself was suspended from the COVID-19 vaccination program and all funds received for the corresponding Medicaid billings were repaid.