On May 18, 2021, in a statement issued by the U.S. Department of Health and Human Services’ (HHS) Office of Inspector General, Acting U.S. Attorney for the Eastern District of California, Phillip Talbert, and California Attorney General, Rob Bonta (the Statement), the health care industry was reminded of the prohibition against charging individuals for COVID-19 vaccines (the Vaccine(s)). The Statement reinforced the Centers for Disease Control and Prevention’s (CDC) mandate that administration of the Vaccine should come at no personal cost to the recipient. The CDC instructs participants that they must (1) administer the Vaccines regardless of a recipient’s ability to pay administration fees or coverage status, (2) provide Vaccines at no out-of-pocket cost to the recipient, and (3) may seek appropriate reimbursement from an appropriate program or plan, such as the recipients insurance policy or the Health Resources and Services Administration’s COVID-19 Uninsured Program, which covers Vaccine administration fees associated with uninsured individuals.
The Statement issued this month comes after the California Attorney General’s office received allegations that entities administering the Vaccine had been charging as much as $45 in out-of-pocket fees to recipients. This reminder serves as a warning of the possible legal consequences of seeking payment directly from individuals for the Vaccine. Such entities could be subject to investigation by the U.S. Department of Justice (DOJ) for violation of the civil False Claims Act, various civil and criminal statutes, and removal from the CDC’s COVID-19 Vaccination Program. In the last few months alone, the DOJ has charged hundreds of individuals who have allegedly abused various COVID-19 relief programs, involving more than $569 million in alleged fraudulent claims.
Although the Statement largely served as a cautionary tale to entities that are inappropriately seeking payment from patients for administration of the Vaccine, HHS also reminded those distributing the Vaccine to seek reimbursement from various sources, including HHS’ COVID-19 Coverage Assistance Fund (CAF), which is intended to compensate providers in instances where a patient has insurance that does not cover vaccines, or does cover vaccines, but includes patient cost-sharing. Services reimbursed by CAF include the costs of training individuals to administer the Vaccine, storing the Vaccines, and the staffing needs involved in administering doses.
Reed Smith continues to track guidance involving the distribution of the Vaccine, and will continue to provide updates moving forward. Should you have any questions related to the distribution of the Vaccine, please do not hesitate to reach out to the health care attorneys at Reed Smith.