‘Gaming the system’
Although most people seeking a booster shot at one of Caswell’s pharmacies are following official recommendations, there are some who remain ineligible but nonetheless come in for an additional vaccine.
“Even before this announcement last Friday, in the latter part of August when the CDC talked about a booster for immunocompromised, we had interest from people who did not meet the criteria,” Mr. Caswell said.
To the ineligible, he and his staff explain the approval process, why certain decisions are made, and point out that the number of eligible Americans is likely to expand in the future.
“The vast majority of them are understanding,” Mr. Caswell said. “But we’ve had some people who really didn’t want to accept the information, and I don’t know what they’ve done.”
“Some people are gaming the system to get their booster or second shot of J&J,” he said.
For example, Mr. Caswell had a patient who crossed over state lines from Missouri seeking a vaccine booster at Wolkar Drug, a pharmacy in Baxter Springs, Kan. “We found out later he had a J&J shot at a facility or provider in Missouri. He came over to Kansas, signed up for it and got a booster with Moderna.”
“We called and asked him if he was aware of it. He said, ‘yes.’ When we questioned him more about it, he hung up.”
Dr. Edje is likewise seeing interest from some ineligible patients, she said.
Crossing a liability line?
Mr. Caswell has asked for advice from lawyers and the State Board of Pharmacy on potential liability if a pharmacist gives a booster to a patient not eligible under the official FDA and CDC guidance.
“We ask patients direct questions about whether they’ve had the COVID vaccine, COVID, and a whole litany of questions they must answer. And we’re assuming they are going to be honest and forthright,” he said. “The pharmacist needs to make sure they make every effort to get that information from the patient.”
Normally, healthcare providers like Mr. Caswell report each COVID-19 vaccination to the state registry after administration. “We have not gone through a police action and checked the registry first,” he said.
But, if people continue to try ‘gaming the system,’ he said, he might have to start checking the state registry before giving someone a booster.
The American Academy of Family Physicians offers advice from the CDC about legal protections for providers.
“As outlined by CDC, any off-label use of the Comirnaty/Pfizer-BioNTech COVID-19 vaccine is not authorized at this time and may not be covered under the PREP Act or the PREP Act declaration. This means that clinicians providing the vaccine outside of the authorized/approved use may not have immunity from claims,” the AAFP website states.
“Per CDC, individuals who receive a third dose may not be eligible for compensation after a possible adverse event. Such use would be in violation of the CDC COVID-19 vaccination program provider agreement and therefore may not be reimbursable and may impact the ability of a provider to remain in the CDC program, in addition to other potential sanctions. Administration fees for off-label doses may not be reimbursed by payers.”