
I remember times when pharmacies were able to prepare and submit prior authorizations (PAs) on behalf of the prescribers. Then, gears shifted and pharmacies were allowed to fill out PAs but not to submit them. Nowadays, the landscape is much stricter and pharmacies are only allowed to prepopulate some information, such as patients’ data. Adding clinical information, signing, and actual submission must be done by the prescriber’s office.
A recent case, which resulted in a criminal conviction and a settlement of over $1 million, illustrates the point.
A Florida pharmacy – OHM Pharmacy Services (Pharmacy) – pled guilty to health care fraud and agreed to settle to resolve False Claims Act violations by paying $82,000 in restitution, and $1,018,000 in penalty.
According to the settlement, the Pharmacy employed several individuals who held the title Patient Assistance Specialists (“PA Specialists”). Among other duties, PA Specialists worked on completing and submitting PA requests for Evzio, as well as certain dermatological products and other drugs. Part D plans require that clinical information be provided directly by representatives of the prescribing physician’s office. PA Specialists, however, completed Evzio prior authorization forms in place of the prescribing physicians, including instances in which PA Specialists signed the prior authorization forms without the physician’s authorization. The Pharmacy then submitted the forms to Medicare Part D plans misrepresenting that the forms were coming directly from prescribers’ offices. On dozens of Evzio prior authorization request forms, PA Specialists listed Pharmacy’s fax numbers instead of the prescribing physician’s fax number. According to the government’s allegations, the Pharmacy did so to ensure that insurers would contact them (and not the listed prescribing physician) when communicating about these PAs.
According to the Pharmacy’s admissions, some PAs contained false clinical information to secure their approval and its payment for the more expensive drug (at the time, Evzio was the most expensive version of naloxone and as such required a PA). For example, PA Specialists filled out and submitted dozens of Evzio PA forms that falsely asserted that patients had previously tried and failed both Narcan and naloxone. Furthermore, the Pharmacy falsely stated on Evzio PA forms that patients had shaky hands or nasal problems.
The case stemmed from a qui tam action (a whistleblower suit). The whistleblower in this case was a former employee of Kaleo Inc (Evzio’s manufacturer). It appears that the manufacturer was aware and even assisted with obtaining PAs. Interestingly, back in 2021, Kaleo Inc settled with the federal government for $12.7 million relating to their submission of false claims for Evzio.