For pharma and a former Warner Chilcott manager, it could have been much worse. Ex-district manager Landon Eckles was sentenced to 1 year of probation and a fine of $10,000 for violating health privacy laws by filling out prior authorization forms for doctors who prescribed the Warner bone med Atelvia.
Eckles, an ex-district manager, overstepped criminal provisions of the Health Insurance Portability and Privacy Act (HIPAA), the U.S. Attorney’s Office in Massachusetts said in announcing Eckles’ guilty plea last year. Eckles had told his sales reps to fill out the insurance forms--required to win reimbursement for the osteoporosis med--if doctors refused to do it themselves. Eckles and the reps used patients’ “protected health information” to fill out those forms, the prosecutors said.
The Warner sales team also used patient charts to push doctors to prescribe: Eckles and one rep put Atelvia brochures in those charts to remind them to write scripts. “Eckles bragged about this tactic to his sales representatives, stating, ‘I guarantee you that this is going to drive business,” the statement said.
At the time of his plea, the DOJ said Eckles faced a maximum penalty of 10 years behind bars, a $250,000 fine and exclusion from the federal Medicare program, which would disqualify him from pharma sales--if his guilty plea didn’t turn off drugmakers already.
Warner is not the only pharma cited for digging into patient charts to help over-stretched physicians and their staff fill out forms required to obtain insurance coverage for their meds. With payers raising more and more hurdles to coverage, drugmakers have sought ways to ease that process so that physicians will write more scripts--and patients fill them--despite the paperwork hassles.
One of those companies is the now-notorious Insys Therapeutics, whose Subsys sales operation has come under fire--and legal attack--for aggressive marketing tactics. According to a class-action lawsuit, reps were trained to pretend they worked in doctors’ offices to win insurance coverage for the med, even for off-label uses beyond its limited approval for cancer pain. The former chief of that prior authorization unit was indicted earlier this month.
Insys’ prior authorization program appears to have required patients to give permission to access their files, however, which would avoid HIPAA violations.
Other companies have taken the HIPAA high road as well; MannKind, the maker of the inhaled insulin Afrezza, is one of them. The company has a program where employees work with patients to get insurance coverage and copay or patient assistance as needed; to enroll, patients have to sign a HIPAA release.
The Warner probe yielded charges against five former employees: two indictments and three guilty pleas, the latter of which included Eckles. Former Warner Chilcott President Carl Reichel was one of those indicted, but he was found not guilty at trial earlier this year.
But despite that verdict, U.S. Attorney Carmen Ortiz told FiercePharma that her office wasn't deterred from prosecuting individual pharma execs for corporate wrongdoing. "Cases against high level business executives are difficult to prove and are hard-fought," Ortiz said in an emailed statement. "Nonetheless, they are essential in order to deter corporate executives from engaging in wrongful conduct that improperly attempts to influence doctors."
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